Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02171520
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches. The test batch was the drug product batch intended for future commercial use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dabigatran etexilate generation I Dabigatran etexilate generation I - Dabigatran etexilate generation II Dabigatran etexilate generation II -
- Primary Outcome Measures
Name Time Method AUC0-infinity (area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration Cmax (maximum measured concentration of total dabigatran in plasma) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration
- Secondary Outcome Measures
Name Time Method λz (terminal rate constant in plasma) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration t1/2 (terminal half-life of the analyte in plasma) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration Cmax (maximum measured concentration of free dabigatran in plasma) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration AUC0-tz (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) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration AUC0-infinity (area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration tmax (time from dosing to the maximum concentration of the analyte in plasma) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration MRTpo (mean residence time of the analyte in the body after oral administration) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration CL/F (apparent clearance of the analyte in the plasma after extravascular administration) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration