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Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 277 tablet | Experimental |
| |
| BIBR 277 capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 277 tablet | Drug |
|
| |
| BIBR 277 capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum observed concentration of the Telmisartan in plasma) | up to 72 hours after drug administration | |
| AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Individual time courses of the Telmisartan plasma concentrations | up to 72 hours after drug administration | |
| tmax (time to reach Cmax) | up to 72 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
|
| t1/2 (terminal half-life of the Telmisartan in plasma) |
| up to 72 hours after drug administration |
| AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity) | up to 72 hours after drug administration |
| MRT0-∞ (total mean residence time of Telmisartan molecules in the body) | up to 72 hours after drug administration |
| Number of subjects with adverse events | up to 72 hours after last drug administration |
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate | up to 72 hours after last drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 72 hours after last drug administration |
| Number of subjects with clinically significant findings in ECG | up to 72 hours after last drug administration |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |