Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers

NCT ID: NCT02259803

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief Summary

Study to investigate the relative bioavailability of fixed-dose combination tablet vs.

mono-components of telmisartan and amlodipine

Conditions

Healthy

Study Design

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

Study Groups

Telmisartan/amlodipine fixed-dose combination

Group Type: EXPERIMENTAL

Telmisartan/amlodipine fixed-dose combination (FDC) tablet

Intervention Type: DRUG

Telmisartan and amlodipine mono-components

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Interventions

Telmisartan/amlodipine fixed-dose combination (FDC) tablet

Intervention Type: DRUG

Telmisartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease

2. Age ≥20 and Age ≤35 years

3. Body weight ≥50 kg

4. BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)

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

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

5. Positive result for hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test

6. Surgery of gastrointestinal tract (except appendectomy)

7. 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

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

9. History of serious renal dysfunction

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

11. History of cerebrovascular disorder

12. History of hyperkalemia

13. Known hypersensitivity to any component of the formulation, or to any other angiotensin II receptor blockers, angiotensin converting enzyme or dihydropyridine

14. 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 prior to administration or during the trial

15. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial

16. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration

17. Smoker (≥20 cigarettes/day)

18. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)

19. Drug abuse

20. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)

21. Excessive physical activities (within 1 week prior to administration or during the trial)

22. Intake of alcohol within 2 days prior to administration

23. Inability to comply with dietary regimen of study centre

24. Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration

25. Inability to refrain from smoking on trial days

26. Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study

• 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

1235.18

Identifier Type: -

Identifier Source: org_study_id