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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBR 277 tablet
* Drug: BIBR 277 capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIBR 277 tablet<br>(Mannitol based) | Drug: BIBR 277 tablet<br> <br> |
| Active Comparator: BIBR 277 capsule<br> | Drug: BIBR 277 capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |