A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I

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Detailed Description

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Conditions

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Healthy Male Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)

Exforge® 10/160

Group Type ACTIVE_COMPARATOR

Exforge®

Intervention Type DRUG

G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)

G-0081

Group Type EXPERIMENTAL

G-0081

Intervention Type DRUG

Interventions

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Exforge®

Intervention Type DRUG

G-0081

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
* having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
* doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria

* Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
* Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
* Gastrointestinal diseases or surgeries that affect absorption of drug
* Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
* Smoking over 10 cigarettes per day

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes