Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02262559 |
Recruitment Status :
Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
|
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 :
- Cmax (maximum observed concentration of the Telmisartan in plasma) [ Time Frame: 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 [ Time Frame: up to 72 hours after drug administration ]
Secondary Outcome Measures :
- Individual time courses of the Telmisartan plasma concentrations [ Time Frame: up to 72 hours after drug administration ]
- tmax (time to reach Cmax) [ Time Frame: up to 72 hours after drug administration ]
- t1/2 (terminal half-life of the Telmisartan in plasma) [ Time Frame: up to 72 hours after drug administration ]
- 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 ]
- MRT0-∞ (total mean residence time of Telmisartan molecules in the body) [ Time Frame: up to 72 hours after drug administration ]
- Number of subjects with adverse events [ Time Frame: up to 72 hours after last drug administration ]
- Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 72 hours after last drug administration ]blood pressure, pulse rate
- Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 72 hours after last drug administration ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
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
No Contacts or Locations Provided
Additional Information:
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:
Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |