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To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS low dose | Experimental |
| |
| BIBR 1048 MS medium dose 1 | Experimental |
| |
| BIBR 1048 MS medium dose 2 | Experimental |
| |
| BIBR 1048 MS high dose | Experimental |
| |
| BIBR 1048 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS low | Drug |
| ||
| BIBR 1048 MS medium 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aPTT (activated partial thromboplastin time) | up to day 10 | |
| Change in PT (prothrombin time) | up to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration) of BIBR 953 ZW | up to day 10 | |
| tmax (time from dosing to the maximum concentration) of BIBR 953 ZW | up to day 10 | |
| AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW |
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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 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 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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|
| BIBR 1048 MS medium 2 | Drug |
|
| BIBR 1048 MS high | Drug |
|
| BIBR 1048 MS placebo | Drug |
|
| up to day 10 |
| Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW | Day 7 |
| Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW | Day 7 |
| Cavg (average plasma concentration at steady state) of BIBR 953 ZW | up to day 10 |
| PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW | up to day 10 |
| tmax,ss (time to reach Cmax) of BIBR 953 ZW | up to day 10 |
| t1/2 (terminal half-life) of BIBR 953 ZW | up to day 10 |
| AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW | up to day 10 |
| MRTss (mean residence time at steady state) of BIBR 953 ZW | up to day 10 |
| CLtot/F (total apparent clearance) of BIBR 953 ZW | up to day 10 |
| Vz/F (apparent volume of distribution) of BIBR 953 ZW | up to day 10 |