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Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: BIBR 277 tablet (Drug); BIBR 277 capsule (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

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

Clinical Details

Official title: Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cmax (maximum observed concentration of the Telmisartan in plasma)

AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr

Secondary outcome:

Individual time courses of the Telmisartan plasma concentrations

tmax (time to reach Cmax)

t1/2 (terminal half-life of the Telmisartan in plasma)

AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)

MRT0-∞ (total mean residence time of Telmisartan molecules in the body)

Number of subjects with adverse events

Number of subjects with clinically significant findings in vital signs

Number of subjects with clinically significant findings in laboratory tests

Number of subjects with clinically significant findings in ECG

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: July 2002
Last updated: October 9, 2014

Page last updated: August 23, 2015

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