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To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate polymorph II | Experimental |
| |
| Dabigatran etexilate polymorph I | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate polymorph II | Drug |
| ||
| Dabigatran etexilate 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:
Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Age ≥60 and ≤85 years
BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
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 with t1 = 0 and t2 = 24, 48, 72 hours (AUCt1-t2) | 24, 48 and 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 68 |
| Change from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 68 |
| Change from baseline in 12-lead electrocardiogram | Baseline, day 68 |
| Change from baseline in clinical laboratory tests | Baseline, day 68 |
| Number of Participants with Serious and Non-Serious Adverse Events | up to day 68 |
| Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) | Day 68 |