Status:
COMPLETED
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
Eligibility Criteria
Inclusion
- Age \>= 20 and \<= 35 years
- Weight: BMI \>= 17.6 and \<= 26.4 (Weight (kg) / Height (m)2)
- Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
- Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
Exclusion
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
- History of serious renal disorder
- History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
- History of or present cerebrovascular disorder
- History of hyperkalemia
- History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
- History of or present orthostatic hypotension or faint
- Surgery of gastrointestinal tract (except appendectomy)
- History of alcohol or drug abuse
- Participation to another trial with an investigational drug within 4 months prior to the trial
- Whole blood donation more than 400 mL within 3 months prior to the trial
- Whole blood donation more than 100 mL within 1 month prior to the trial
- Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
- Any medication which might influence the result of the trial within 10 days prior to the trial
- Excessive physical activities within 7 days prior to the trial
- Alcohol drinking within 3 days prior to the trial
- Inability to comply with restriction of protocol
- Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02262559
Start Date
July 1 2002
Last Update
October 13 2014
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