Compare characteristics and safety after administration of clopidgrel 75mg & aspirin 100mg complex with those of clopidogrel 75mg & aspirin 100mg coadministratio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0000384
- Lead Sponsor
- Dong-A Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
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
-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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax of clopidogrel & acetylsalicylic acid;AUClast of clopidogrel & acetylsalicylic acid
- Secondary Outcome Measures
Name Time Method Cmax of salicylic acid;AUClast of salicylic acid