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Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02710630
Recruitment Status : Completed
First Posted : March 17, 2016
Results First Posted : September 29, 2017
Last Update Posted : November 6, 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 tablet E1
Drug: Dabigatran etexilate tablet D1
Drug: Dabigatran etexilate tablet C1
Drug: Dabigatran etexilate tablet B1
Drug: Dabigatran etexilate tablet A1
Drug: Dabigatran etexilate capsule
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ref-A1-B1-C1-D1-E1 Ref-B1-C1-D1-E1-A1 Ref-C1-D1-E1-A1-B1 Ref-D1-E1-A1-B1-C1 Ref-E1-A1-B1-C1-D1
Hide Arm/Group Description

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

Period Title: Period 1
Started 7 7 7 7 7
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Period Title: Period 2
Started 7 7 7 7 7
Not Treated 1 0 0 0 0
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Period Title: Period 3
Started 7 7 7 7 7
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Period Title: Period 4
Started 7 7 7 7 7
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Period Title: Period 5
Started 7 7 7 7 7
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Period Title: Period 6
Started 7 7 7 7 7
Completed 7 7 7 7 7
Not Completed 0 0 0 0 0
Arm/Group Title Ref-A1-B1-C1-D1-E1 Ref-B1-C1-D1-E1-A1 Ref-C1-D1-E1-A1-B1 Ref-D1-E1-A1-B1-C1 Ref-E1-A1-B1-C1-D1 Total
Hide Arm/Group Description

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.

A washout period of at least 4 days was set following the drug administration in each period.

Total of all reporting groups
Overall Number of Baseline Participants 7 7 7 7 7 35
Hide Baseline Analysis Population Description
Treated set (TS): This set included all subjects that were dispensed study drug and were documented to have taken at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 7 participants 7 participants 7 participants 35 participants
26.9  (2.4) 28.1  (3.4) 27.3  (3.4) 29.1  (3.6) 27.4  (3.4) 27.8  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 7 participants 7 participants 35 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
35
 100.0%
1.Primary Outcome
Title AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Hide Description This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.
Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 35 35 35 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
600
(51.8%)
714
(42.1%)
318
(327%)
354
(96.6%)
649
(78.6%)
661
(54.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 119.33
Confidence Interval (2-Sided) 90%
101.838 to 139.834
Parameter Dispersion
Type: Standard Deviation
Value: 40.4
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 52.97
Confidence Interval (2-Sided) 90%
33.341 to 84.158
Parameter Dispersion
Type: Standard Deviation
Value: 168.9
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 59.01
Confidence Interval (2-Sided) 90%
45.255 to 76.955
Parameter Dispersion
Type: Standard Deviation
Value: 73.4
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 108.21
Confidence Interval (2-Sided) 90%
87.698 to 133.530
Parameter Dispersion
Type: Standard Deviation
Value: 55.7
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 110.21
Confidence Interval (2-Sided) 90%
93.939 to 129.297
Parameter Dispersion
Type: Standard Deviation
Value: 41.1
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

2.Primary Outcome
Title Cmax (Maximum Concentration of Free Dabigatran)
Hide Description This outcome measure presents maximum concentration of analyte in plasma (Cmax).
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.
Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 35 35 35 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
73.5
(60.0%)
86.8
(39.3%)
42.3
(213%)
45.5
(81.5%)
79.6
(73.5%)
79.2
(52.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 118.31
Confidence Interval (2-Sided) 90%
99.569 to 140.579
Parameter Dispersion
Type: Standard Deviation
Value: 44.2
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 57.49
Confidence Interval (2-Sided) 90%
38.502 to 85.837
Parameter Dispersion
Type: Standard Deviation
Value: 132.3
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 61.94
Confidence Interval (2-Sided) 90%
48.130 to 79.720
Parameter Dispersion
Type: Standard Deviation
Value: 69.0
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 108.26
Confidence Interval (2-Sided) 90%
87.704 to 133.629
Parameter Dispersion
Type: Standard Deviation
Value: 55.8
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 107.76
Confidence Interval (2-Sided) 90%
91.238 to 127.281
Parameter Dispersion
Type: Standard Deviation
Value: 43.0
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

3.Secondary Outcome
Title AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
Hide Description This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description

The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.

PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.

PKS2 was used for statistical analyses.

Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 31 32 34 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
623
(49.0%)
735
(40.2%)
544
(71.9%)
444
(60.3%)
725
(53.0%)
684
(51.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 118.26
Confidence Interval (2-Sided) 90%
101.627 to 137.621
Parameter Dispersion
Type: Standard Deviation
Value: 38.5
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 87.26
Confidence Interval (2-Sided) 90%
69.404 to 109.722
Parameter Dispersion
Type: Standard Deviation
Value: 60.2
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 71.40
Confidence Interval (2-Sided) 90%
58.828 to 86.648
Parameter Dispersion
Type: Standard Deviation
Value: 49.2
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 116.67
Confidence Interval (2-Sided) 90%
100.516 to 135.410
Parameter Dispersion
Type: Standard Deviation
Value: 37.7
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 109.85
Confidence Interval (2-Sided) 90%
94.452 to 127.750
Parameter Dispersion
Type: Standard Deviation
Value: 38.7
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

4.Secondary Outcome
Title AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Hide Description This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description

The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.

PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.

PKS2 was used for statistical analyses.

Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 35 35 35 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
726
(52.9%)
838
(41.1%)
366
(341%)
412
(97.1%)
777
(74.9%)
778
(53.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 115.69
Confidence Interval (2-Sided) 90%
98.783 to 135.491
Parameter Dispersion
Type: Standard Deviation
Value: 40.2
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 50.43
Confidence Interval (2-Sided) 90%
31.519 to 80.689
Parameter Dispersion
Type: Standard Deviation
Value: 173.7
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 56.71
Confidence Interval (2-Sided) 90%
43.388 to 74.122
Parameter Dispersion
Type: Standard Deviation
Value: 74.2
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 106.99
Confidence Interval (2-Sided) 90%
87.554 to 130.732
Parameter Dispersion
Type: Standard Deviation
Value: 52.8
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 107.07
Confidence Interval (2-Sided) 90%
91.399 to 125.432
Parameter Dispersion
Type: Standard Deviation
Value: 40.7
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

5.Secondary Outcome
Title Cmax (Maximum Plasma Concentration of Total Dabigatran)
Hide Description This outcome measure presents maximum concentration of analyte in plasma (Cmax).
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description

The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.

PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.

PKS2 was used for statistical analyses.

Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 35 35 35 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
88.6
(62.0%)
102
(39.0%)
47.9
(227%)
52.2
(83.6%)
94.2
(75.7%)
91.9
(54.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 115.39
Confidence Interval (2-Sided) 90%
96.740 to 137.644
Parameter Dispersion
Type: Standard Deviation
Value: 45.3
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 54.12
Confidence Interval (2-Sided) 90%
35.818 to 81.774
Parameter Dispersion
Type: Standard Deviation
Value: 138.6
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 58.96
Confidence Interval (2-Sided) 90%
45.489 to 76.431
Parameter Dispersion
Type: Standard Deviation
Value: 71.4
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 106.38
Confidence Interval (2-Sided) 90%
85.846 to 131.836
Parameter Dispersion
Type: Standard Deviation
Value: 57.0
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 103.73
Confidence Interval (2-Sided) 90%
87.740 to 122.628
Parameter Dispersion
Type: Standard Deviation
Value: 43.3
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

6.Secondary Outcome
Title AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
Hide Description This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).
Time Frame 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description

The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.

PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.

PKS2 was used for statistical analyses.

Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description:
The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 35 34 31 32 35 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
750
(50.5%)
863
(39.1%)
628
(75.6%)
515
(60.1%)
804
(70.1%)
800
(51.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: A1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 115.27
Confidence Interval (2-Sided) 90%
99.063 to 134.130
Parameter Dispersion
Type: Standard Deviation
Value: 38.4
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: B1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 83.73
Confidence Interval (2-Sided) 90%
66.033 to 106.163
Parameter Dispersion
Type: Standard Deviation
Value: 62.8
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: C1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 68.77
Confidence Interval (2-Sided) 90%
56.452 to 83.782
Parameter Dispersion
Type: Standard Deviation
Value: 50.3
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: D1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 107.13
Confidence Interval (2-Sided) 90%
88.616 to 129.510
Parameter Dispersion
Type: Standard Deviation
Value: 49.6
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate Tablet: E1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio [Test/Reference]
Estimated Value 106.64
Confidence Interval (2-Sided) 90%
91.625 to 124.114
Parameter Dispersion
Type: Standard Deviation
Value: 38.9
Estimation Comments

The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Time Frame From first drug administration until 1 day after last drug administration, up to 81 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Hide Arm/Group Description The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours. The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours. The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours. The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours. The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours. The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
All-Cause Mortality
Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (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 Capsule: Ref Dabigatran Etexilate Tablet: A1 Dabigatran Etexilate Tablet: B1 Dabigatran Etexilate Tablet: C1 Dabigatran Etexilate Tablet: D1 Dabigatran Etexilate Tablet: E1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
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
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02710630     History of Changes
Other Study ID Numbers: 1160.246
First Submitted: March 14, 2016
First Posted: March 17, 2016
Results First Submitted: May 8, 2017
Results First Posted: September 29, 2017
Last Update Posted: November 6, 2017