Healthy
Conditions
Brief summary
Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet
Interventions
DRUGTelmisartan film-coated tablet
DRUGTelmisartan uncoated tablet
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 Japanese males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests * 1.1 No findings deviating from normal and of clinical relevance * 1.2 No evidence of a clinically relevant concomitant disease 2. Age ≥20 and ≤35 years 3. Body weight≥50kg 4. Body Mass Index ≥18.0 and ≤25.0 kg/m2 5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion criteria
1. Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. Chronic or relevant acute infections 6. History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients) 7. Any clinical relevant findings of the laboratory test deviating from normal 8. Positive result for either hepatitis B antigen, anti hepatitis C virus antibodies, syphilitic test or human immunodeficiency virus (HIV) test 9. History of surgery of gastrointestinal tract (except appendectomy) 10. 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 11. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis) 12. History of serious renal dysfunction 13. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney 14. History of cerebrovascular disorder 15. History of hyperkalemia 16. Known hypersensitivity to any component of the telmisartan formulation, or to any other angiotensin II receptor blockers 17. 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 before administration of the investigational product 18. Use of any drugs within 10 days before administration of the investigational product or during the trial 19. Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial 20. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 21. Alcohol abuse 22. Drug abuse 23. Blood donation (100 mL or more) within four weeks before administration of the investigational product 24. Excessive physical activities within one week before administration of the investigational product or during the trial 25. Intake of alcohol within 2 days prior to administration 26. Inability to comply with dietary regimen of study centre 27. Inability to refrain from smoking on trial days 28. Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point (AUC0-tz) | up to 72 hours after drug administration |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 72 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal rate constant of the analyte in plasma (λz) | up to 72 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 72 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 72 hours after drug administration |
| Number of subjects with adverse events | up to 72 hours after last drug administration |
| mean residence time of the analyte in the body after po administration (MRTpo) | up to 72 hours after drug administration |
| Time from dosing to the maximum measured concentration of the analyte in plasma (tmax) | up to 72 hours after drug administration |
Outcome results
None listed