Clinical trial NCT02262585: Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
Official title: Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Cmax (maximum observed concentration of the Telmisartan in plasma)
timeFrame: up to 72 hours after drug administration
measure: AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
timeFrame: up to 72 hours after drug administration
Secondary outcomes:
measure: Individual time courses of the Telmisartan plasma concentrations
timeFrame: up to 72 hours after drug administration
measure: tmax (time to reach Cmax)
timeFrame: up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the Telmisartan in plasma)
timeFrame: up to 72 hours after drug administration
measure: AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)
timeFrame: up to 72 hours after drug administration
measure: MRT0-∞ (total mean residence time of Telmisartan molecules in the body)
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with clinically significant findings in ECG
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 72 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: