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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 277 capsule; Drug: BIBR 277 tablet

• Registration Number: NCT02262585
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2002-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIBR 277 capsule	BIBR 277 capsule	-
BIBR 277 tablet	BIBR 277 tablet	(Mannitol based)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Individual time courses of the Telmisartan plasma concentrations	up to 72 hours after drug administration
tmax (time to reach Cmax)	up to 72 hours after drug administration
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
Number of subjects with adverse events	up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs	up to 72 hours after drug administration	blood pressure, pulse rate
Number of subjects with clinically significant findings in ECG	up to 72 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests	up to 72 hours after drug administration