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Trial record 48 of 914 for:    tablet | Japan

Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan

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ClinicalTrials.gov Identifier: NCT03143166
Recruitment Status : Completed
First Posted : May 8, 2017
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-alcoholic Fatty Liver Disease
Interventions Drug: Dabigatran Etexilate
Drug: Rabeprazol sodium
Enrollment 36
Recruitment Details This was open label, 2 period, fixed sequence (RT), single arm study in 36 healthy male Japanese subjects. All subjects were orally treated with single dose of 110 milligram (mg) dabigatran etexilate (DE) tablet formulation alone in period 1 and with 20 mg rabeprazole tablet in period 2 with 4 days of rabeprazole pre-medication.
Pre-assignment Details After it had been determined that the subject met all eligibility criteria, a unique subject number was assigned. The number was recorded on electronic Case Report Forms and correspondence regarding the subject. Once a subject number had been assigned, it could not be reassigned to any other subject. Randomisation was not planned in this study.
Arm/Group Title Dabigatran Etexilate 110 mg With and Without Rabeprazole 20 mg
Hide Arm/Group Description Subjects were treated orally with dabigatran etexilate 110 mg tablet alone (Reference) after an overnight fast of at least 10 hours (h) without pretreatment with rabeprazole 20 mg tablet in period 1 followed by single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets (Test) once daily with 4 days of rabeprazole pre-treatment in period 2. The treatments of dabigatran etexilate were separated by a wash-out phase of at least 4 days.
Period Title: Period 1
Started 36
Completed 36
Not Completed 0
Period Title: Period 2 (Washout of at Least 4 Days)
Started 36
Completed 35
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Total Subjects
Hide Arm/Group Description Subjects were treated orally with dabigatran etexilate 110 mg tablet alone (Reference) after an overnight fast of at least 10 hours (h) without pretreatment with rabeprazole 20 mg tablet in period 1 followed by single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets (Test) once daily with 4 days of rabeprazole pre-treatment in period 2. The treatments of dabigatran etexilate were separated by a wash-out phase of at least 4 days.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
Treated set (TS) : All enrolled subjects provided with trial medication and documented to have taken at least 1 dose of trial medication were included in the TS.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
26.3  (4.7)
[1]
Measure Description: Age of all subjects enrolled in the study.
[2]
Measure Analysis Population Description: TS
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
0
   0.0%
Male
36
 100.0%
[1]
Measure Description: Gender distribution of all subjects enrolled in the study.
[2]
Measure Analysis Population Description: TS
Ethnicity (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
36
 100.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Description: Ethnicity of all subjects enrolled in the study.
[2]
Measure Analysis Population Description: TS
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
36
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Description: Race of all subjects enrolled in the study.
[2]
Measure Analysis Population Description: TS
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz).
Hide Description This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): All treated subjects who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints were included in PKS.
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*Hour/ millilitre (ng*h/mL)
667
(123%)
192
(109%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 28.85
Confidence Interval (2-Sided) 90%
21.346 to 38.996
Parameter Dispersion
Type: Standard Error of the Mean
Value: 86.7
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
2.Primary Outcome
Title Maximum Concentration of Total Dabigatran in Plasma (Cmax).
Hide Description This outcome is maximum measured concentration of the total dabigatran in plasma
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nano gram per milliliter (ng/mL)
83.1
(118%)
21.8
(105%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 26.37
Confidence Interval (2-Sided) 90%
20.066 to 34.665
Parameter Dispersion
Type: Standard Error of the Mean
Value: 76.6
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
3.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz).
Hide Description This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*Hour/ millilitre (ng*h/mL)
588
(119%)
164
(110%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 28.02
Confidence Interval (2-Sided) 90%
20.914 to 37.537
Parameter Dispersion
Type: Standard Error of the Mean
Value: 83.4
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
4.Secondary Outcome
Title Maximum Concentration of Free Dabigatran in Plasma (Cmax).
Hide Description This outcome is maximum measured concentration of the free dabigatran in plasma
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter (ng/mL)
72.9
(114%)
20.0
(103%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 27.56
Confidence Interval (2-Sided) 90%
21.023 to 36.118
Parameter Dispersion
Type: Standard Error of the Mean
Value: 75.6
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
5.Secondary Outcome
Title Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Hide Description This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*Hour/ millilitre (ng*h/mL)
702
(110%)
214
(96.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 30.59
Confidence Interval (2-Sided) 90%
23.260 to 40.234
Parameter Dispersion
Type: Standard Error of the Mean
Value: 76.8
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
6.Secondary Outcome
Title Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Hide Description This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Time Frame Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Hide Arm/Group Description:
Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*Hour/ millilitre (ng*h/mL)
618
(107%)
188
(93.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate 110 mg (Reference), Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments An analysis of variance (ANOVA) was used on the logarithmic scale including effects for ‘subjects’ and ‘treatment’.
Method of Estimation Estimation Parameter Adjusted gMean ratio Test/Reference (%)
Estimated Value 30.61
Confidence Interval (2-Sided) 90%
23.404 to 40.037
Parameter Dispersion
Type: Standard Error of the Mean
Value: 74.9
Estimation Comments The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).
Time Frame From first drug administration until 3 days after the last drug administration. Up to 10 days.
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a medicinal product and which did not necessarily have to have a causal relationship with this treatment. Treated Set was used for assessment of AEs.
 
Arm/Group Title Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg (Test)
Hide Arm/Group Description Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet. Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
All-Cause Mortality
Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (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 110 mg (Reference) Dabigatran Etexilate 110 mg + Rabeprazole 20 mg (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (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: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03143166     History of Changes
Other Study ID Numbers: 1160-0270
First Submitted: May 4, 2017
First Posted: May 8, 2017
Results First Submitted: July 24, 2018
Results First Posted: January 16, 2019
Last Update Posted: January 16, 2019