Healthy
Conditions
Brief summary
Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition 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
1. Healthy male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests 2. Age: ≥20 and Age ≤35 years 3. Body weight: ≥50 kg 4. Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2 5. Signed and dated written informed consent prior to admission to the trial in accordance with the 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 or neurological disorders 3. Chronic or relevant acute infections 4. Any clinical relevant findings in laboratory test results deviating from normal 5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test 6. History of surgery of the 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 amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound 9. Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration 10. Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration 11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration 12. Smoker (≥20 cigarettes/day) 13. Alcohol abuse (60 g or more ethanol/day: e.g., 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 before drug administration) 16. Excessive physical activities (within 1 week before drug administration) 17. Intake of alcohol within 2 days before drug administration 18. Inability to comply with dietary regimen of the study centre 19. Inability to refrain from smoking during trial days 20. Subjects judged to be inappropriate by the investigator or a sub-investigator
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 time of the last quantifiable data point (AUC0-tz) | up to 144 hours after drug administration |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 144 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal rate constant of the analyte in plasma (λz) | up to 144 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 144 hours after drug administration |
| 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 drug administration |
| Number of subjects with adverse events | up to 56 days |
| Mean residence time of the analyte in the body after po administration (MRTpo) | up to 144 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | up to 144 hours after drug administration |
Outcome results
None listed