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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan/Amlodipine low dose; Other: Japanese meal; Drug: Telmisartan/Amlodipine high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261064

1235.27

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Telmisartan/Amlodipine low dose, fed

Experimental group

Description:

Telmisartan low dose/Amlodipine fixed-dose combination

Treatment:

Other: Japanese meal

Drug: Telmisartan/Amlodipine low dose

Telmisartan/Amlodipine low dose, fasted

Active Comparator group

Description:

Telmisartan low dose/Amlodipine fixed-dose combination

Treatment:

Drug: Telmisartan/Amlodipine low dose

Telmisartan/Amlodipine high dose, fed

Experimental group

Description:

Telmisartan high dose/Amlodipine fixed-dose combination

Treatment:

Drug: Telmisartan/Amlodipine high dose

Other: Japanese meal

Telmisartan/Amlodipine high dose, fasted

Active Comparator group

Description:

Telmisartan high dose/Amlodipine fixed-dose combination

Treatment:

Drug: Telmisartan/Amlodipine high dose