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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G0041(75/100mg)

Group Type EXPERIMENTAL

G0041(75/100mg)

Intervention Type DRUG

G0041(75/100mg) 2 capsules(Clopidogrel 75mg \& Aspirin 100mg in 1 capsule), PO

Clopidogrel & Aspirin

Group Type ACTIVE_COMPARATOR

Clopidogrel & Aspirin

Intervention Type DRUG

Clopidogrel 75mg 2 tablets \& Aspirin 100mg 2 capsules, PO

Interventions

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G0041(75/100mg)

G0041(75/100mg) 2 capsules(Clopidogrel 75mg \& Aspirin 100mg in 1 capsule), PO

Intervention Type DRUG

Clopidogrel & Aspirin

Clopidogrel 75mg 2 tablets \& Aspirin 100mg 2 capsules, PO

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes