Healthy
Conditions
Brief summary
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
Interventions
DRUGBIBR 277 tablet
DRUGBIBR 277 capsule
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age \>= 20 and \<= 35 years 2. Weight: BMI \>= 17.6 and \<= 26.4 (Weight (kg) / Height (m)2) 3. Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening 4. Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
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. History of hepatic disorder (e.g., biliary cirrhosis, cholestasis) 5. History of serious renal disorder 6. History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis 7. History of or present cerebrovascular disorder 8. History of hyperkalemia 9. History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists 10. History of or present orthostatic hypotension or faint 11. Surgery of gastrointestinal tract (except appendectomy) 12. History of alcohol or drug abuse 13. Participation to another trial with an investigational drug within 4 months prior to the trial 14. Whole blood donation more than 400 mL within 3 months prior to the trial 15. Whole blood donation more than 100 mL within 1 month prior to the trial 16. Donation of constituent of blood of more than 400 mL within 1 month prior to the trial 17. Any medication which might influence the result of the trial within 10 days prior to the trial 18. Excessive physical activities within 7 days prior to the trial 19. Alcohol drinking within 3 days prior to the trial 20. Inability to comply with restriction of protocol 21. Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum observed concentration of the Telmisartan in plasma) | up to 72 hours after drug administration |
| AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr | up to 72 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 (terminal half-life of the Telmisartan in plasma) | up to 72 hours after drug administration | — |
| AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity) | up to 72 hours after drug administration | — |
| MRT0-∞ (total mean residence time of Telmisartan molecules in the body) | up to 72 hours after drug administration | — |
| Individual time courses of the Telmisartan plasma concentrations | up to 72 hours after drug administration | — |
| Number of subjects with clinically significant findings in vital signs | up to 72 hours after last drug administration | blood pressure, pulse rate |
| Number of subjects with clinically significant findings in laboratory tests | up to 72 hours after last drug administration | — |
| Number of subjects with clinically significant findings in ECG | up to 72 hours after last drug administration | — |
| Number of subjects with adverse events | up to 72 hours after last drug administration | — |
| tmax (time to reach Cmax) | up to 72 hours after drug administration | — |
Outcome results
None listed