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To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS | Experimental |
| |
| BIBR 1048 MS + Pantoprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS - low dose | Drug |
| ||
| BIBR 1048 MS - high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of total BIBR 953 ZW | Day 1, day 2, day 3 (different time points) | |
| Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW | Day 1, day 2, day 3 (different time points) | |
| Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW | Day 1, day 2, day 3 (different time points) | |
| Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval | Day 1, day 2, day 3 (different time points) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW | Day 1, day 2, day 3 (different time points) | |
| Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration | Day 1, day 2, day 3 (different time points) |
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Inclusion Criteria:
Exclusion Criteria:
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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 + Pantoprazole | Drug |
|
| Occurence of adverse events | 6 weeks |
| Change from Baseline in pulse rate | Baseline, day 1,day 2, day 3, day 4 |
| Change from Baseline in systolic and diastolic blood pressure | Baseline, day 1,day 2, day 3, day 4 |
| Change from Baseline in clinical laboratory tests | Baseline, day 1,day 2, day 3, day 4 |
| Changes from baseline in activated partial thromboplastin time (aPTT) | Day 1, day 2, day 3 (different time points) |
| Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR)) | Day 1, day 2, day 3 (different time points) |
| Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration | ay 1, day 2, day 3 (different time points) |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |