Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Japanese meal; Drug: Hydrochlorothiazide (HCTZ); Drug: Telmisartan low; Drug: Telmisartan high

Study type: Interventional

Funder types: Industry

Identifiers

NCT02276378

502.569

Details and patient eligibility

About

To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers

Enrollment: 32 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy males according to the following criteria:

1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
2. Age ≥20 and Age ≤35 years
3. Body weight ≥50 kg
4. BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
5. Signed and dated written informed consent prior to admission to the study in accordance with 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 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 either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
6. History of surgery of 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 hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
9. 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
10. 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
11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
12. Smoker (≥20 cigarettes/day)
13. Alcohol abuse (60 g or more ethanol/day: ex. 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 prior to administration or during the trial)
16. Excessive physical activities (within 1 week prior to administration or during the trial)
17. Intake of alcohol within 2 days prior to administration
18. Inability to comply with dietary regimen of study centre
19. Inability to refrain from smoking on trial days
20. Subjects judged to be inappropriate by the investigator or the 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 low / HCTZ fixed-dose combination, fed

Experimental group

Treatment:

Other: Japanese meal

Drug: Hydrochlorothiazide (HCTZ)

Drug: Telmisartan low

Telmisartan high / HCTZ fixed-dose combination, fed

Experimental group

Treatment:

Other: Japanese meal

Drug: Hydrochlorothiazide (HCTZ)

Drug: Telmisartan high

Telmisartan low /HCTZ fixed-dose combination, fasted

Active Comparator group

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Drug: Telmisartan low

Telmisartan high /HCTZ fixed-dose combination, fasted

Active Comparator group

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Drug: Telmisartan high