NCT Number: NCT02262585
Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
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Notify MeKey information
Conditions
Age range
20 year–35 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BIBR 277 capsule
DrugPrimary outcomes
-
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 outcomes
-
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 drug administration
-
Number of subjects with clinically significant findings in vital signs
Time frame: up to 72 hours after drug administration
blood pressure, pulse rate
-
Number of subjects with clinically significant findings in ECG
Time frame: up to 72 hours after drug administration
-
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 72 hours after drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
Important dates
- Study start
- 2002
- Primary completion
- 2002
- First posted
- Oct 13, 2014
- Registry last updated
- Oct 13, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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