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Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four 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 + Pantoprazole | Experimental | Five treatments with oral administration of 50 mg BIBR 1048 MS (bid for 3 days) and 40 mg Pantoprazole (bid). Randomised sequence. BIBR 1048 MS Capsule E with pantoprazole; BIBR 1048 MS Capsule F with pantoprazole; BIBR 1048 MS Capsule G with pantoprazole; BIBR 1048 MS Tablet H with pantoprazole; BIBR 1048 MS Drinking solution with pantoprazole |
|
| Period 2: BIBR 1048 MS | Experimental | Three treatments (fixed sequence) with oral administration of 50 mg BIBR 1048 MS (bid for 3 days).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS Capsule E | Drug | 50 mg BIBR 1048 MS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of BIBR 953 ZW excreted into urine over one dose interval (Ae0-12) | Day 1 to 16 of each treatment period | |
| 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 of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
History of 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 which 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 F | Drug | 50 mg BIBR 1048 MS |
|
| BIBR 1048 MS Capsule G | Drug | 50 mg BIBR 1048 MS |
|
| BIBR 1048 MS Tablet H | Drug | 50 mg BIBR 1048 MS |
|
| BIBR 1048 MS Drinking solution | Drug | 50 mg BIBR 1048 MS tartaric acid solution |
|
| Pantoprazole | Drug | 40 mg Pantoprazole |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |