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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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