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Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan alone | Active Comparator |
| |
| Telmisartan + Clopidogrel (concomitantly) | Experimental |
| |
| Telmisartan + Clopidogrel (consecutively) | Experimental |
| |
| Clopidogrel alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours post dose | |
| Cmax (maximum concentration of the analyte in plasma) | up to 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 8 days after last drug administration | |
| Number of subjects with clinically significant findings in vital signs | up to 8 days after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| Clopidogrel |
| Drug |
|
| Number of subjects with clinically significant findings in ECG | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in labortory test | up to 8 days after last drug administration |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 72 hours post dose |
| AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72 hours post dose |
| λz (terminal rate constant in plasma) | up to 72 hours post dose |
| t1/2 (terminal half-life of the analytes in plasma) | up to 72 hours post dose |
| MRTpo (mean residence time of the analytes in the body after po administration) | up to 72 hours post dose |
| CL/F (apparent clearance of the analytes in the plasma after extravascular administration) | up to 72 hours post dose |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours post dose |
| CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2) | up to 72 hours post dose |
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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