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Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a 150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1018 MS HPMC capsule fasted | Experimental |
| |
| BIBR 1048 MS HPMC capsule after high fat meal | Experimental |
| |
| BIBR 1048 MS gelatine capsule fasted | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS HPMC capsule | Drug |
| ||
| BIBR 1048 MS gelatine capsule |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the plasma concentration time curve from zero time extrapolated to infinity) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | |
| AUC0-tz (The area under the plasma concentration time curve from zero time to the time of the last quantifiable concentration) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | |
| Cmax (maximum measured concentration) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | |
| tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| t½ (terminal half-life) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug | |
| MRT (Total mean residence time) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug |
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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 within 1 month 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 clinically accepted reference range
History of any familial bleeding disorder
Thrombocytes < 150000/μl
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| Drug |
|
| CL/F (Total apparent clearance) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug |
| Vz/F (Apparent volume of distribution) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug |