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To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate batch A | Experimental |
| |
| Dabigatran etexilate batch B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) | Drug |
| ||
| Dabigatran polymorph I |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 72 hours after drug administration | |
| Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax) | Up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 72 hours after drug administration | |
| Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax) | Up to 72 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| 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) | Up to 72 hours after drug administration |
| Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 (AUCt1-t2) | t1 = 0 and t2 = 24, 48, 72 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | Up to 72 hours after drug administration |
| Terminal rate constant in plasma (λz) | Up to 72 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | Up to 72 hours after drug administration |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | Up to 72 hours after drug administration |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F ) | Up to 72 hours after drug administration |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | Up to 72 hours after drug administration |
| Change from baseline in physical examination | Baseline, day 73 |
| Change from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 73 |
| Change from baseline in 12-lead ECG (electrocardiogram) | Baseline, day 73 |
| Change from baseline in clinical laboratory tests | Baseline, day 73 |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to day 73 |
| Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) | Day 73 |