Healthy
Conditions
Brief summary
To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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: 1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests 2. Age ≥20 and Age ≤35 years 3. Body weight ≥50 kg 4. BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index) 5. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.
Exclusion criteria
1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 3. Chronic or relevant acute infections 4. Any clinical relevant findings of the laboratory test deviating from normal 5. Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test 6. History of surgery of gastrointestinal tract (except appendectomy) 7. History of relevant orthostatic hypotension, fainting spells or blackouts 8. Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone) 9. 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 10. 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 11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration 12. Smoker (≥20 cigarettes/day) 13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake) 14. Drug abuse 15. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial) 16. Excessive physical activities (within 1 week prior to administration or during the trial) 17. Intake of alcohol within 2 days prior to administration 18. Inability to comply with dietary regimen of study centre 19. Inability to refrain from smoking on trial days 20. Subjects judged to be inappropriate by the investigator or the sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | Up to 72 hours after drug administration |
| The maximum measured concentration of the analyte in the plasma (Cmax) | Up to 72 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal rate constant in the plasma (λz) | Up to 72 hours after drug administration |
| Terminal half-life of the analyte in the plasma (t1/2) | Up to 72 hours after drug administration |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | Up to 72 hours after drug administration |
| Number of participants with abnormal findings in physical examination | Up to 72 hours after drug administration |
| Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 72 hours after drug administration |
| Number of participants with clinically significant findings in 12-lead ECG | Up to 72 hours after drug administration |
| Number of participants with clinically significant findings in clinical laboratory parameters | Up to 72 hours after drug administration |
| Number of participants with adverse events | Up to 7 days after drug administration |
| Number of participants with clinically significant findings in vital signs | Up to 72 hours after last drug administration |
| Time from dosing to the maximum concentration of the analyte in the plasma (tmax) | Up to 72 hours after drug administration |
Outcome results
None listed