Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Mannitol; Telmisartan

Criteria

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