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To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 capsule | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax) | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| time to maximum plasma concentration (Tmax) | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| total clearance of drug from plasma | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| terminal elimination constant | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| time of last measureable BIBR 953 ZW plasma concentration (Tf) | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| area under the plasma concentration time curve until Tf (AUC0-Tf) | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose | |
| area under the plasma concentration time extrapolated to infinity (AUC0-infinity) | pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | up to 24 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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