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

Study Overview
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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.

Official Title
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A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: G0041(75/100mg)
* Drug: Clopidogrel & Aspirin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G0041(75/100mg)<br> | Drug: G0041(75/100mg)<br>* G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO<br>|
| Active Comparator: Clopidogrel & Aspirin<br> | Drug: Clopidogrel & Aspirin<br>* Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, Aspirin, coadministration