Healthy
Conditions
Brief summary
Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet
Interventions
DRUGTelmisartan film coated tablet
DRUGTelmisartan conventional 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
Healthy males according to the following criteria: 1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests * No findings deviating from normal and of clinical relevance * No evidence of a clinically relevant concomitant disease 2. Age ≥20 and ≤35 years 3. Body mass index (BMI) ≥17.6 and ≤26.4 kg/m2 4. 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 antigen (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 (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 telmisartan formulation, or to any other angiotensin II receptor blockers (ARBs) 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. Inability to refrain from smoking on trial days
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 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 | Description |
|---|---|---|
| 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 subjects with adverse events | up to 72 hours after last 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 subjects with clinically significant findings in 12-lead electrocardiogram | up to 72 hours after last administration | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 72 hours after last administration | — |
| Number of subjects with clinically significant findings in physical examination | up to 72 hours after last administration | — |
| Number of subjects with clinically significant findings in vital signs | up to 72 hours after last administration | blood pressure, pulse rate, body temperature |
| 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