Healthy
Conditions
Brief summary
Study to investigate the relative bioavailability of fixed-dose combination tablet vs. mono-components of telmisartan and amlodipine
Interventions
DRUGTelmisartan/amlodipine fixed-dose combination tablet
DRUGTelmisartan
DRUGAmlodipine
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
Inclusion criteria
1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease 2. Age ≥20 and Age ≤35 years 3. Body weight ≥50 kg 4. BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index) 5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice
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 hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test 6. Surgery of gastrointestinal tract (except appendectomy) 7. History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts 8. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis) 9. History of serious renal dysfunction 10. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney 11. History of cerebrovascular disorder 12. History of hyperkalemia 13. Known hypersensitivity to any component of the formulation, or to any other angiotensin II receptor antagonists, angiotensin converting enzyme or dihydropyridine 14. 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 15. 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 16. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration 17. Smoker (≥20 cigarettes/day) 18. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake) 19. Drug abuse 20. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial) 21. Excessive physical activities (within 1 week prior to administration or during the trial) 22. Intake of alcohol within 2 days prior to administration 23. Inability to comply with dietary regimen of study centre 24. Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration 25. Inability to refrain from smoking on trial days 26. Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | up to 144 hours after administration of study drug |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 144 hours after administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Time from administration to the maximum concentration of the analyte in plasma (tmax) | up to 144 hours after administration of study drug |
| Terminal rate constant of the analyte in plasma (λz) | up to 144 hours after administration of study drug |
| Number of subjects with clinically significant changes in laboratory tests | up to 144 hours after administration of study drug |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 144 hours after administration of study drug |
| Terminal half-life of the analyte in plasma (t1/2) | up to 144 hours after administration of study drug |
| Mean residence time of the analyte in the body after po administration (MRTpo) | up to 144 hours after administration of study drug |
| Number of subjects with adverse events | up to 56 days |
| Number of subjects with clinically significant changes in vital signs | up to 144 hours after administration of study drug |
| Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram) | up to 144 hours after administration of study drug |
Outcome results
None listed