Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-07-31

Brief Summary

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Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects

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Detailed Description

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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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(R)(T)

Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg

Group Type ACTIVE_COMPARATOR

Fimasartan

Intervention Type DRUG

Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg

(T)(R)

Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg

Group Type ACTIVE_COMPARATOR

Fimasartan

Intervention Type DRUG

Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg

Interventions

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Fimasartan

Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg

Intervention Type DRUG

Fimasartan

Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age: 20 - 55 years
* body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
* written informed consent

Exclusion Criteria

* known allergy to Fimasartan
* 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
* abnormal diet which could affect drug absorption or metabolism
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day
* participation in a clinical trial during the last 90 days prior to the start of the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes