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To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ vs. its monocomponents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/HCTZ fixed dose | Experimental |
| |
| Telmisartan and HCTZ monocomponents | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Hydrochlorthiazide (HCTZ) |
| 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 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 concentration of the analyte in plasma) | Up to 72 hours after drug administration |
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Inclusion Criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, the physical examination (physical findings and measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
Age ≥20 years and Age ≤35 years
BMI ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)(MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation.
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 |
|
| Telmisartan/HCTZ fixed dose | Drug |
|
| 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 abnormal findings in physical examination | Up to 9 days after last drug administration |
| Number of participants with clinically significant findings in vital signs | Up to 9 days after last drug administration |
| Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) | Up to 9 days after last drug administration |
| Number of participants with clinically significant findings in laboratory parameters | Up to 9 days after last drug administration |
| Number of participants with adverse events | Up to 9 days after last drug administration |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |