Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers

NCT ID: NCT02261064

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31

Brief Summary

Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.

Conditions

Healthy

Study Design

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

Study Groups

Telmisartan/Amlodipine low dose, fed

Telmisartan low dose/Amlodipine fixed-dose combination

Group Type: EXPERIMENTAL

Telmisartan/Amlodipine low dose

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Telmisartan/Amlodipine low dose, fasted

Telmisartan low dose/Amlodipine fixed-dose combination

Group Type: ACTIVE_COMPARATOR

Telmisartan/Amlodipine low dose

Intervention Type: DRUG

Telmisartan/Amlodipine high dose, fed

Telmisartan high dose/Amlodipine fixed-dose combination

Group Type: EXPERIMENTAL

Telmisartan/Amlodipine high dose

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Telmisartan/Amlodipine high dose, fasted

Telmisartan high dose/Amlodipine fixed-dose combination

Group Type: ACTIVE_COMPARATOR

Telmisartan/Amlodipine high dose

Intervention Type: DRUG

Interventions

Telmisartan/Amlodipine low dose

Intervention Type: DRUG

Telmisartan/Amlodipine high dose

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests

2. Age: ≥20 and Age ≤35 years

3. Body weight: ≥50 kg

4. Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2

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

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 or neurological disorders

3. Chronic or relevant acute infections

4. Any clinical relevant findings in laboratory test results deviating from normal

5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test

6. History of surgery of the gastrointestinal tract (except appendectomy)

7. History of relevant orthostatic hypotension, fainting spells, or blackouts

8. Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound

9. Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration

10. Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration

11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration

12. Smoker (≥20 cigarettes/day)

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

14. Drug abuse

15. Blood donation (more than 100 mL within 4 weeks before drug administration)

16. Excessive physical activities (within 1 week before drug administration)

17. Intake of alcohol within 2 days before drug administration

18. Inability to comply with dietary regimen of the study centre

19. Inability to refrain from smoking during trial days

20. Subjects judged to be inappropriate by the investigator or a sub-investigator

• 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

1235.27

Identifier Type: -

Identifier Source: org_study_id