Healthy
Conditions
Brief summary
To establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets
Interventions
DRUGTelmisartan/HCTZ combination
DRUGTelmisartan
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 Japanese 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. Body Mass Index (BMI) ≥18.0 and BMI ≤25.0 kg/m2 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. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis) 10. History of serious renal dysfunction 11. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney 12. History of cerebrovascular disorder 13. History of hyperkalemia 14. History of impaired glucose tolerance 15. History of hypokalemia 16. History of hyperuricemia 17. Salt restriction therapy 18. 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 19. 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 20. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration 21. Smoker (≥20 cigarettes /day)) 22. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake) 23. Drug abuse 24. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial) 25. Excessive physical activities (within 1 week prior to administration or during the trial) 26. Intake of alcohol within 2 days prior to administration 27. Inability to comply with dietary regimen of study centre 28. Inability to refrain from smoking on trial days 29. Subjects judged to be inappropriate by the investigator or the sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 72 hours after last drug administration |
| 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 |
| Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) | Up to 72 hours after last drug administration |
| Number of participants with clinically significant findings in clinical laboratory parameters | Up to 72 hours after last drug administration |
| Number of participants with adverse events | Up to 72 hours after last drug administration |
| Number of participants with clinically significant findings in vital signs | Up to 72 hours after last drug administration |
| tmax (time from dosing to the maximum measured concentration of the analyte in plasma) | Up to 72 hours after drug administration |
Outcome results
None listed