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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02262585
• Date of registration: 09/10/2014
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
• Scientific title: Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation in Healthy Male Volunteers
• Date of first enrolment: July 2002
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02262585
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: BIBR 277 tablet

Drug: BIBR 277 capsule

Primary Outcome(s)

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]

Cmax (maximum observed concentration of the Telmisartan in plasma) [Time Frame: up to 72 hours after drug administration]

Secondary Outcome(s)

tmax (time to reach Cmax) [Time Frame: up to 72 hours after drug administration]

MRT0-8 (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 laboratory tests [Time Frame: up to 72 hours after drug administration]

Number of subjects with clinically significant findings in ECG [Time Frame: up to 72 hours after drug administration]

AUC0-8(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity) [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]

Individual time courses of the Telmisartan plasma concentrations [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]

Secondary ID(s)

502.417

Source(s) of Monetary Support

Please refer to primary and secondary sponsors