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Group 1:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)
Group 2:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single low dose Telmisartan with HCTZ | Experimental |
| |
| Single high dose Telmisartan with HCTZ | Experimental |
| |
| Multiple high dose Telmisartan with HCTZ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of telmisartan | Drug |
| ||
| High dose of telmisartan |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically relevant findings in physical examination | up to 10 days after last drug administration | |
| Number of patients with clinically relevant findings in vital signs | blood pressure, pulse rate, body temperature | up to 10 days after last drug administration |
| Number of patients with clinically relevant findings in 12-lead ECG | up to 10 days after last drug administration | |
| Number of patients with clinically relevant findings in clinical laboratory tests | up to 10 days after last drug administration | |
| Number of patients with adverse events | up to 10 days after last drug administration | |
| Global assessment of tolerability by the investigator | verbal rating scale | up to 10 days after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analytes in plasma (Cmax) | Up to 96 hours after drug administration | |
| Area under the concentration time curve of the analytes in plasma (AUC) | Up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| HCTZ | Drug |
|
| Time from dosing to maximum concentration of the analytes in plasma (tmax) | Up to 96 hours after drug administration |
| Terminal rate constant of the analytes in plasma (λz) | Up to 96 hours after drug administration |
| Terminal half-life of the analytes in plasma (t1/2) | Up to 96 hours after drug administration |
| Mean residence time of the analytes in the body after po administration (MRTpo) | Up to 96 hours after drug administration |
| Apparent clearance of the analytes in the plasma after extravascular administration (CL/F) | Up to 96 hours after drug administration |
| Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F) | Up to 96 hours after drug administration |
| Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2) | Up to 48 hours after drug administration |
| Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2) | Up to 48 hours after drug administration |
| Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2) | Up to 48 hours after drug administration |
| Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | Up to 96 hours after drug administration |
| Average concentration of the analytes in plasma at steady state (Cavg) | Up to 96 hours after drug administration |
| Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA) | Up to 96 hours after drug administration |
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D006852 | Hydrochlorothiazide |
| 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 |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
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