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Trial record 43 of 333 for:    DABIGATRAN

Bioavailability of Different Applications of Dabigatran in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02171611
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : April 25, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Dabigatran etexilate pellets
Drug: Dabigatran etexilate powder
Drug: Dabigatran etexilate capsule
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A/B/C A/C/B B/A/C B/C/A C/A/B C/B/A
Hide Arm/Group Description

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.

Treatments were separated by washout period of at least 7 days after drug administration.

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject.

Treatments were separated by washout period of at least 7 days after drug administration.

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.

Treatments were separated by washout period of at least 7 days after drug administration.

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.

Treatments were separated by washout period of at least 7 days after drug administration.

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration.

Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.

Treatments were separated by washout period of at least 7 days after drug administration.

Period Title: Overall Study
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C)
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment. This set was used for safety analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
39.8  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
10
  33.3%
Male
20
  66.7%
1.Primary Outcome
Title AUC0-inf for Total Dabigatran
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax.
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng(nanogram)*h(hour)/mL(milliliter)
599
(93.3%)
1050
(33.8%)
928
(32.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means
Estimated Value 175.14
Confidence Interval (2-Sided) 90%
141.904 to 216.149
Parameter Dispersion
Type: Standard Error of the Mean
Value: 50.7
Estimation Comments Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means
Estimated Value 154.84
Confidence Interval (2-Sided) 90%
127.425 to 188.161
Parameter Dispersion
Type: Standard Error of the Mean
Value: 46.6
Estimation Comments Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
2.Primary Outcome
Title AUC0-inf for Free Dabigatran
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
464
(97.3%)
815
(40%)
734
(38.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 175.4
Confidence Interval (2-Sided) 90%
141.924 to 216.772
Parameter Dispersion
Type: Standard Error of the Mean
Value: 51.1
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 158.12
Confidence Interval (2-Sided) 90%
130.052 to 192.255
Parameter Dispersion
Type: Standard Error of the Mean
Value: 46.7
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
3.Primary Outcome
Title Cmax for Total Dabigatran
Hide Description Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
74.6
(110%)
139
(37.8%)
124
(37%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means
Estimated Value 186.94
Confidence Interval (2-Sided) 90%
147.659 to 236.665
Parameter Dispersion
Type: Standard Error of the Mean
Value: 57.7
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 166.59
Confidence Interval (2-Sided) 90%
133.221 to 208.326
Parameter Dispersion
Type: Standard Error of the Mean
Value: 54.3
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
4.Primary Outcome
Title Cmax for Free Dabigatran
Hide Description Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
61.5
(110%)
112
(40.4%)
103
(40.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 181.6
Confidence Interval (2-Sided) 90%
145.428 to 226.776
Parameter Dispersion
Type: Standard Error of the Mean
Value: 53.9
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 166.83
Confidence Interval (2-Sided) 90%
134.25 to 207.328
Parameter Dispersion
Type: Standard Error of the Mean
Value: 52.6
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).
5.Secondary Outcome
Title AUC0-tz for Total Dabigatran
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
565
(106%)
1030
(34.2%)
908
(33.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 182.17
Confidence Interval (2-Sided) 90%
144.727 to 229.297
Parameter Dispersion
Type: Standard Error of the Mean
Value: 56.1
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 160.74
Confidence Interval (2-Sided) 90%
129.633 to 199.306
Parameter Dispersion
Type: Standard Error of the Mean
Value: 52
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
6.Secondary Outcome
Title AUC0-tz for Free Dabigatran
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
436
(110%)
794
(41.3%)
715
(39.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Pellets: Test 1 (B)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 182.25
Confidence Interval (2-Sided) 90%
144.993 to 229.075
Parameter Dispersion
Type: Standard Error of the Mean
Value: 55.7
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 150 mg Capsule: Reference (A), Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Comments An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means in %
Estimated Value 164.01
Confidence Interval (2-Sided) 90%
132.421 to 203.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 51.7
Estimation Comments Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
7.Secondary Outcome
Title Tmax for Total Dabigatran
Hide Description Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Median (Full Range)
Unit of Measure: hour
2.0
(1.5 to 6.0)
1.5
(1.0 to 3.0)
1.5
(1.0 to 2.5)
8.Secondary Outcome
Title Tmax for Free Dabigatran
Hide Description Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Median (Full Range)
Unit of Measure: hour
2.0
(1.5 to 6.0)
1.51
(1.0 to 3.0)
1.5
(1.0 to 2.0)
9.Secondary Outcome
Title λz for Total Dabigatran
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hour
0.079
(13.5%)
0.074
(14.5%)
0.0756
(16.4%)
10.Secondary Outcome
Title λz for Free Dabigatran
Hide Description [Not Specified]
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hour
0.091
(16%)
0.0811
(18.6%)
0.0893
(15.7%)
11.Secondary Outcome
Title t1/2 for Total Dabigatran
Hide Description Terminal half-life of the analyte in plasma (t1/2) for total dabigatran
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
8.77
(13.5%)
9.37
(14.5%)
9.16
(16.4%)
12.Secondary Outcome
Title t1/2 for Free Dabigatran
Hide Description Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
7.62
(16%)
8.54
(18.6%)
7.76
(15.7%)
13.Secondary Outcome
Title MRTpo for Total Dabigatran
Hide Description Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
10.8
(12%)
10.1
(11.4%)
10
(12.2%)
14.Secondary Outcome
Title MRTpo for Free Dabigatran
Hide Description Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
9.9
(14.0%)
9.58
(14.1%)
9.15
(12.2%)
15.Secondary Outcome
Title CL/F for Total Dabigatran
Hide Description Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
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pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL (milliliter)/min (minute)
3130
(93.3%)
1790
(33.8%)
2020
(32.8%)
16.Secondary Outcome
Title CL/F for Free Dabigatran
Hide Description Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL (milliliter)/min (minute)
4040
(97.3%)
2310
(40%)
2560
(38.2%)
17.Secondary Outcome
Title Vz/F for Total Dabigatran
Hide Description Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
2380
(92.8%)
1450
(35%)
1610
(35.9%)
18.Secondary Outcome
Title Vz/F for Free Dabigatran
Hide Description Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.
Time Frame -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic per-protocol set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
2670
(91%)
1700
(41.4%)
1720
(37.6%)
19.Secondary Outcome
Title Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.
Hide Description

Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.

There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests.

Time Frame From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
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Treated Set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0 0.0
20.Secondary Outcome
Title Percentage of Participants With Drug-related Adverse Events
Hide Description Percentage of participants with investigator defined drug−releated Adverse events.
Time Frame From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
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Treated set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Measure Type: Number
Unit of Measure: Percentage of participants
6.7 23.3 26.7
21.Secondary Outcome
Title Assessment of Tolerability by Investigator.
Hide Description Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.
Time Frame From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
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Treated Set
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description:
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 30 30 30
Measure Type: Number
Unit of Measure: Percentage of Participants
Good 100.0 100.0 100.0
Satisfactory 0.0 0.0 0.0
Not satisfactory 0.0 0.0 0.0
Bad 0.0 0.0 0.0
Not assessable 0.0 0.0 0.0
Time Frame From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Hide Arm/Group Description Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water. Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject. Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
All-Cause Mortality
Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate 150 mg Capsule: Reference (A) Dabigatran Etexilate 150 mg Pellets: Test 1 (B) Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)   7/30 (23.33%)   8/30 (26.67%) 
Gastrointestinal disorders       
Abdominal pain upper  1  0/30 (0.00%)  2/30 (6.67%)  0/30 (0.00%) 
Nervous system disorders       
Headache  1  2/30 (6.67%)  5/30 (16.67%)  8/30 (26.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171611     History of Changes
Other Study ID Numbers: 1160.87
First Submitted: June 20, 2014
First Posted: June 24, 2014
Results First Submitted: March 15, 2017
Results First Posted: April 25, 2017
Last Update Posted: May 23, 2017