Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers

NCT ID: NCT02261129

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

Brief Summary

Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan, film-coated tablet

one tablet of telmisartan

Group Type: EXPERIMENTAL

Telmisartan film-coated tablet

Intervention Type: DRUG

Telmisartan, conventional tablet

Two tablets of telmisartan

Group Type: ACTIVE_COMPARATOR

Telmisartan uncoated tablet

Intervention Type: DRUG

Interventions

Telmisartan film-coated tablet

Intervention Type: DRUG

Telmisartan uncoated tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Japanese males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (Blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests

• 1.1 No findings deviating from normal and of clinical relevance
• 1.2 No evidence of a clinically relevant concomitant disease

2. Age ≥20 and ≤35 years

3. Body weight≥50kg

4. Body Mass Index ≥18.0 and ≤25.0 kg/m2

5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

5. Chronic or relevant acute infections

6. History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)

7. Any clinical relevant findings of the laboratory test deviating from normal

8. Positive result for either hepatitis B antigen, anti hepatitis C virus antibodies, syphilitic test or human immunodeficiency virus (HIV) test

9. History of surgery of gastrointestinal tract (except appendectomy)

10. History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts

11. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)

12. History of serious renal dysfunction

13. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney

14. History of cerebrovascular disorder

15. History of hyperkalemia

16. Known hypersensitivity to any component of the telmisartan formulation, or to any other angiotensin II receptor blockers

17. Intake of drugs with a long half-life (≥24 hours) within at least one month or less than 10 half-lives of the respective drug before administration of the investigational product

18. Use of any drugs within 10 days before administration of the investigational product or during the trial

19. Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial

20. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

21. Alcohol abuse

22. Drug abuse

23. Blood donation (100 mL or more) within four weeks before administration of the investigational product

24. Excessive physical activities within one week before administration of the investigational product or during the trial

25. Intake of alcohol within 2 days prior to administration

26. Inability to comply with dietary regimen of study centre

27. Inability to refrain from smoking on trial days

28. Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.557

Identifier Type: -

Identifier Source: org_study_id