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Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/Amlodipine low dose, fed | Experimental | Telmisartan low dose/Amlodipine fixed-dose combination |
|
| Telmisartan/Amlodipine low dose, fasted | Active Comparator | Telmisartan low dose/Amlodipine fixed-dose combination |
|
| Telmisartan/Amlodipine high dose, fed | Experimental | Telmisartan high dose/Amlodipine fixed-dose combination |
|
| Telmisartan/Amlodipine high dose, fasted | Active Comparator | Telmisartan high dose/Amlodipine fixed-dose combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Amlodipine low dose | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 (AUC0-tz) | up to 144 hours after drug administration | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 144 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 144 hours after drug administration | |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Telmisartan/Amlodipine high dose |
| Drug |
|
| Japanese meal | Other |
|
| up to 144 hours after drug administration |
| Terminal rate constant of the analyte in plasma (λz) | up to 144 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 144 hours after drug administration |
| Mean residence time of the analyte in the body after po administration (MRTpo) | up to 144 hours after drug administration |
| Number of subjects with adverse events | up to 56 days |
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| 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 |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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