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To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 low1 | Experimental | Two treatments of one single dose of BIBR 1048 12.5 mg without or with Pantoprazole
|
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| BIBR 1048 low2 | Experimental | Two treatments of one single dose of BIBR 1048 25 mg without or with Pantoprazole
|
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| BIBR 1048 medium | Experimental | Two treatments of one single dose of BIBR 1048 50 mg without or with Pantoprazole
|
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| BIBR 1048 high | Experimental | Two treatments of one single dose of BIBR 1048 100 mg without or with Pantoprazole
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 low1 | Drug |
| ||
| BIBR 1048 low2 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug | |
| AUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum measured concentration) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug | |
| tmax (Time from dosing to the maximum concentration) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
History of 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 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 medium | Drug |
|
| BIBR 1048 high | Drug |
|
| Pantoprazole | Drug |
|
| MRTtot (Total mean residence time) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug |
| CLtot/F (Total apparent clearance) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 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, 12, 24 and 48 hours after administration of study drug |
| λz (terminal elimination rate constant) of BIBR 953 ZW | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug |
| changes in activated partial thromboplastin time (aPTT) | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug |
| changes in international normalized ratio (INR) | Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 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 |