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To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs. its monocomponents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/HCTZ fixed combination | 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, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of clinical relevance 2) No evidence of a clinically relevant concomitant disease
Age ≥ 20 years and age ≤ 35 years
Body Mass Index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
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 combination | 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 clinically significant 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 |