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To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS without Pantoprazole | Experimental | 150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day |
|
| BIBR 1048 MS with Pantoprazole | Experimental | 150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day together with Pantoprazole. Pantoprazole administration (40 mg bid) started two days before administration og BIBR 1048 and ended in the morning of the seventh day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS | Drug | BIBR 1048 MS capsule 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss (area under the plasma concentration time curve during a dosing interval at steady state) | Day 4 and 7 | |
| Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval Ï„) | Day 4 and 7 | |
| Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state) | Day 4 and 7 | |
| feτ,ss (percent of dose excreted in urine over one dosing interval at steady state) | Day 4 and 7 | |
| AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz)) | Day 4 and 7 | |
| Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval Ï„) | Day 4 and 7 | |
| tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval Ï„) | Day 4 and 7 | |
| t½,ss (terminal half-life, calculated from the terminal elimination rate constant) | Day 4 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| CLR,ss (renal clearance at steady state following multiple dose administration) | Day 4 and 7 | |
| MRTss (steady state mean residence time) | Day 4 and 7 | |
| CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration) |
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Inclusion Criteria:
Exclusion Criteria:
Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
History of relevant 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 that 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 intake (>30 - 40 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 < 140000/μl (male) or < 156000/μl (female)
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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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| Pantoprazole | Drug | Pantoprazole tablet 40 mg |
|
| Day 4 and 7 |
| Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) | Day 4 and 7 |
| Changes in activated partial thromboplastin time (aPTT) | Day 4 and 7 |
| Changes in ecarin clotting time (ECT) | Day 4 and 7 |
| Occurrence of Adverse Events | up to 10 days |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |