Healthy
Conditions
Brief summary
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)
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males according to the following criteria: No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests * Age ≥20 and Age ≤35 years * Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2 * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)
Exclusion criteria
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Chronic or relevant acute infections * Any laboratory value outside the reference range that is of clinical relevance * Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or HIV test * Surgery of gastrointestinal tract (except appendectomy) * History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg from mean supine systolic blood pressure (SBP) and/or mean standing diastolic blood pressure (DBP) varies by ≥ 10 mmHg from mean supine DBP), fainting spells or blackouts. * History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis) * History of serious renal dysfunction * History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney * History of cerebrovascular disorder * History of hyperkalemia * Known hypersensitivity to any component of the formulation; known hypersensitivity to any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides) * History of impaired glucose tolerance * History of hypokalemia * History of hyperuricemia * Salt restriction therapy * Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial * Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial * Participation in another trial with an investigational drug within four months or 6 half-lives of the investigational drug, whichever is longer, prior to administration or during the trial * Smoker (more than 20 cigarettes /day) * Alcohol abuse * Drug abuse * Blood donation (more than 100 mL within four weeks prior to administration or during the trial) * Excessive physical activities (within seven days prior to administration) * Intake of alcohol within two days prior to administration * Inability to comply with dietary regimen of study centre * Inability to comply with smoking cessation during hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 10 days after last drug administration | blood pressure, pulse rate, body temperature |
| 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 | up to 10 days after last drug administration | verbal rating scale |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum concentration of the analytes in plasma (Cmax) | Up to 96 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 |
| 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 |
| Area under the concentration time curve of the analytes in plasma (AUC) | Up to 96 hours after drug administration |
| 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 |
Outcome results
None listed