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

A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers

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.

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