Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

Dong-A ST Co., Ltd.65 enrolled

Overview

The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets \& Aspirin 100mg 2 capsules coadministration in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atherosclerosis

Interventions

G0041(75/100mg)DRUG

G0041(75/100mg) 2 capsules(Clopidogrel 75mg \& Aspirin 100mg in 1 capsule), PO

Clopidogrel & AspirinDRUG

Clopidogrel 75mg 2 tablets \& Aspirin 100mg 2 capsules, PO

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male volunteers between the ages of 20 to 50 years old * weight more than 55kg and within the range of ±20% of IBW * having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination * doctor determines to be suitable as subjects within 3 weeks ago before administration Exclusion Criteria: * Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel * Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin * Exceed the normal range of PT, aPTT, BT \& platelet counts under 150,000/㎣ or exceed 350,000/㎣ * Creatinine clearance \< 80 mL/min * Gastrointestinal diseases or surgeries that affect absorption of drug * Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption * Excessive drinking(exceed 21units/week) * Smoking over 10 cigarettes per day