Status:
COMPLETED
Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Atherosclerosis
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief 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 coadminis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01526122
Start Date
September 1 2011
End Date
December 1 2011
Last Update
October 1 2014
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