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

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ClinicalTrials.gov Identifier: NCT02262559
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBR 277 tablet Drug: BIBR 277 capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
Study Start Date : July 2002
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: BIBR 277 tablet Drug: BIBR 277 tablet
Other Name: Telmisartan

Active Comparator: BIBR 277 capsule Drug: BIBR 277 capsule
Other Name: Telmisartan




Primary Outcome Measures :
  1. Cmax (maximum observed concentration of the Telmisartan in plasma) [ Time Frame: up to 72 hours after drug administration ]
  2. AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr [ Time Frame: up to 72 hours after drug administration ]

Secondary Outcome Measures :
  1. Individual time courses of the Telmisartan plasma concentrations [ Time Frame: up to 72 hours after drug administration ]
  2. tmax (time to reach Cmax) [ Time Frame: up to 72 hours after drug administration ]
  3. t1/2 (terminal half-life of the Telmisartan in plasma) [ Time Frame: up to 72 hours after drug administration ]
  4. AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity) [ Time Frame: up to 72 hours after drug administration ]
  5. MRT0-∞ (total mean residence time of Telmisartan molecules in the body) [ Time Frame: up to 72 hours after drug administration ]
  6. Number of subjects with adverse events [ Time Frame: up to 72 hours after last drug administration ]
  7. Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 72 hours after last drug administration ]
    blood pressure, pulse rate

  8. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 72 hours after last drug administration ]
  9. Number of subjects with clinically significant findings in ECG [ Time Frame: up to 72 hours after last drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02262559    
Other Study ID Numbers: 502.414
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action