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Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after administration of 50 mg of BIBR 1048 bid over three days each administered as two experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: BIBR 1048 MS with Pantoprazole | Experimental | Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) with 40 mg Pantoprazole (bid). Randomised sequence.
|
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| Period 2: BIBR 1048 MS | Experimental | Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) without Pantoprazole. Fixed sequence.
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS Capsule I | Drug | 25 mg BIBR 1048 MS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of BIBR 953 ZW excreted into urine during one dosing interval (Ae0-12) | Day 1 to day 10 | |
| AUCss (Area under the plasma concentration-time curve at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period | |
| tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period |
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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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| BIBR 1048 MS Capsule K |
| Drug |
50 mg BIBR 1048 MS |
|
| Pantoprazole | Drug | 40 mg pantoprazole |
|
| BIBR 1048 MS drinking solution | Drug | 50 mg BIBR 1048 MS powder plus solution |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |