Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

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Detailed Description

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Purpose:

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Telmisartan80mg/Amlodipin5mg FDC

single-dose, four-period replicated crossover design

Group Type EXPERIMENTAL

Telmisartan/Amlodipin FDC

Intervention Type DRUG

Telmisartan80mg/Amlodipin5mg FDC

Telmisartan80mgtab + Amlodipin5mg tab

single-dose, four-period replicated crossover design

Group Type EXPERIMENTAL

Telmisartan

Intervention Type DRUG

Telmisartan 80 mg tablet

Amlodipin

Intervention Type DRUG

Amlodipin 5mg tablet

Interventions

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Telmisartan/Amlodipin FDC

Telmisartan80mg/Amlodipin5mg FDC

Intervention Type DRUG

Telmisartan

Telmisartan 80 mg tablet

Intervention Type DRUG

Amlodipin

Amlodipin 5mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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 =35 years
3. Body weight: =50 kg and =80 kg
4. Body mass index (BMI): =18.0 and =25.0 kg/m2

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 syphilis 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 receptor blocker, or to any other dihydropyridine calcium channel blocker 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 1 months or less than 10 times of 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 (ex. Marathon etc) 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 site
19. Inability to refrain from smoking during trial days

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes