Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/HCTZ fixed-dose combination | Experimental |
| |
| Telmisartan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/HCTZ combination | Drug |
| ||
| Telmisartan |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (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 drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | Up to 72 hours after drug administration |
| 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 after drug administration | |
| tmax (time from dosing to the maximum measured concentration of the analyte in plasma) |
Not provided
Inclusion Criteria:
Healthy Japanese males according to the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Up to 72 hours after drug administration |
| λz (terminal rate constant of the analyte in plasma) | Up to 72 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | Up to 72 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after po administration) | Up to 72 hours after drug administration |
| Number of participants with clinically significant findings in physical examination | Up to 72 hours after last drug administration |
| Number of participants with clinically significant findings in vital signs | Up to 72 hours after last drug administration |
| Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) | Up to 72 hours after last drug administration |
| Number of participants with clinically significant findings in clinical laboratory parameters | Up to 72 hours after last drug administration |
| Number of participants with adverse events | Up to 72 hours after last drug administration |
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| 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 |
Not provided
Not provided