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The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and 80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril. Therefore the relative bioavailability of telmisartan and ramipril given in combination was determined in comparison with either telmisartan or ramipril given alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan + Ramipril | Experimental | 5 days qd |
|
| Telmisartan | Active Comparator | 5 days qd |
|
| Ramipril | Active Comparator | 5 days qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss (area under the concentration-time curve in plasma at steady state over a uniform dosing interval τ) | up to 72 hours after last drug administration of each treatment | |
| Cmax,ss (maximum measured concentration in plasma at steady state over a uniform dosing interval τ) | up to 72 hours after last drug administration of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of the analytes in plasma | 2, 4, and 12 hours after administration of the first dose of each treatment on day 1 | |
| pre-dose concentration of the analytes in plasma immediately before the administration of the next dose | pre-dose up to day 5 of each treatment |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Ramipril |
| Drug |
|
|
| tmax,ss (time from last dosing to the maximum concentration of the analytes in plasma at steady state) | up to 72 hours after last drug administration of each treatment |
| Cmin,ss (minimum concentration of the analytes in plasma at steady state over a uniform dosing interval τ) | up to 72 hours after last drug administration of each treatment |
| Cpre,ss (pre-dose concentration of the analytes in plasma immediately before the administration of the next dose at steady state) | pre-dose up to day 5 of each treatment |
| Cavg (average concentration of the analytes in plasma at steady state) | up to 72 hours after last drug administration of each treatment |
| λz,ss (terminal rate constant in plasma at steady state) | up to 72 hours after last drug administration of each treatment |
| t1/2, ss (terminal half-life of the analyte in plasma at steady state) | up to 72 hours after last drug administration of each treatment |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) | up to 72 hours after last drug administration of each treatment |
| CL/F,ss (apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration) | up to 72 hours after last drug administration of each treatment |
| Vz/F,ss (apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration) | up to 72 hours after last drug administration of each treatment |
| PTF (Peak-Trough Fluctuation) | up to 72 hours after last drug administration of each treatment |
| AUC0-tz,ss (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72 hours after last drug administration of each treatment |
| Number of patients with adverse events | up to day 76 |
| Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse rate) | up to day 76 |
| Number of patients with clinically relevant changes in 12-lead electrocardiogram | up to day 76 |
| Number of patients with clinically relevant changes in laboratory tests | up to day 76 |
| Assessment of tolerability by the investigator on a 4-point scale | Day 8 of each treatment |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |