A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Part A

Group Type ACTIVE_COMPARATOR

Fimasartan

Intervention Type DRUG

Fimasartan (1d\~7d) Amlodipine (12d\~14d) Fimasartan + Amlodipine(15d\~21d)

Part B

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine (1d\~10d) Amlodipine (25d\~27d) Fimasartan + Amlodipine(28d\~34d)

Interventions

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Fimasartan

Fimasartan (1d\~7d) Amlodipine (12d\~14d) Fimasartan + Amlodipine(15d\~21d)

Intervention Type DRUG

Amlodipine

Amlodipine (1d\~10d) Amlodipine (25d\~27d) Fimasartan + Amlodipine(28d\~34d)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria

* known allergy to Fimasartan and amlodipine
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism
* history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes