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To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule formulation with and without coadministration of 40 mg Pantoprazole and to assess the effect of food on rate and extent of absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS capsule | Experimental |
| |
| BIBR 1048 capsule with pantoprazole | Experimental |
| |
| BIBR 1048 capsule with food | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under curve of BIBR 953 ZW in plasma over the time interval from 0 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-tf (area under the plasma concentration-time curve of BIBR 953 ZW over the time interval from 0 to the last quantifiable data point) 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 concentration of drug in plasma) 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 elimination 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 | |
| MRTtot (mean time of residence of drug molecules in the body after oral dosing) 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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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pantoprazole |
| Drug |
|
| CLtot/F (total clearance after oral administration) 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 during the terminal phase) 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 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |