A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin 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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.

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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

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Digoxin + Fimasartan

Digoxin (7 days), Digoxin + Fimasartan (7 days)

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 digoxin
* 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