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Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph I in HPMC capsules
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS polymorph II | Experimental |
| |
| BIBR 1048 MS polymorph I | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS polymorph II | Drug |
| ||
| BIBR 1048 MS polymorph I |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration | |
| AUC0-tz | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration | |
| Cmax (maximum measured plasma concentration of BIBR 953 ZW) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses ) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration | |
| t1/2 (half life) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
History of relevant orthostatic hypotension, fainting spells and blackouts
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
History of
Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within 2 months prior to administration or during trial
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation of more than 400 ml within 4 weeks prior to administration or during the trial
Excessive physical activities within 5 days prior to administration or during the trial
Any laboratory value outside the reference range of clinical relevance
History of any familial bleeding disorder
Platelets < 150000/μl
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| Drug |
|
| MRTpo (mean time of residence of drug molecules in the body) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration |
| CL/F (apparent clearance after oral administration) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration |
| Vz/F (apparent volume of distribution) | 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration |
| Changes in ECG | up to 31 days |
| Changes in systolic and diastolic blood pressure | up to 31 days |
| Occurrence of adverse events | up to 31 days |
| Assessment of tolerability by investigator on a four-point scale | up to 31 days |