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

Phase 1

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: G0041(75/100mg); Drug: Clopidogrel & Aspirin

• Registration Number: NCT01526122
• Lead Sponsor: Dong-A ST Co., Ltd.

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 coadministration in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G0041(75/100mg)	G0041(75/100mg)	-
Clopidogrel & Aspirin	Clopidogrel & Aspirin	-

Primary Outcome Measures

Name	Time	Method
AUC(last) of Clopidogrel	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
C(max) of Acetylsalicylic acid	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
C(max) of Clopidogrel	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
AUC(last) of Acetylsalicylic acid	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

Secondary Outcome Measures

Name	Time	Method
C(max) of Salicylic acid	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
AUC(last) of Salicylic acid	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h