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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 277 tablet; Drug: BIBR 277 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262585

502.417

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

BIBR 277 tablet

Experimental group

Description:

(Mannitol based)

Treatment:

Drug: BIBR 277 tablet

BIBR 277 capsule

Active Comparator group

Treatment:

Drug: BIBR 277 capsule