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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIBR 277 tablet; Drug: BIBR 277 capsule

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBR 277 tablet; (Mannitol based)	Drug: BIBR 277 tablet
Active Comparator: BIBR 277 capsule	Drug: BIBR 277 capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	blood pressure, pulse rate	up to 72 hours after drug administration
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.417