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

NCT ID: NCT02276378

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

Telmisartan low / HCTZ fixed-dose combination, fed

Group Type: EXPERIMENTAL

Telmisartan low

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Telmisartan high / HCTZ fixed-dose combination, fed

Group Type: EXPERIMENTAL

Telmisartan high

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Telmisartan low /HCTZ fixed-dose combination, fasted

Group Type: ACTIVE_COMPARATOR

Telmisartan low

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

Telmisartan high /HCTZ fixed-dose combination, fasted

Group Type: ACTIVE_COMPARATOR

Telmisartan high

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

Interventions

Telmisartan low

Intervention Type: DRUG

Telmisartan high

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

Japanese meal

Intervention Type: OTHER

Eligibility Criteria

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

• 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

502.569

Identifier Type: -

Identifier Source: org_study_id