Comparative Pharmacokinetics of YH14659

Study Overview
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Brief Summary
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The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.

Official Title
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Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: YH14659
* Drug: clopidogrel & aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug Healthy male volunteers of aged between 20 years to 55 years Have standard weight of ≤ ±20% based on Broca index* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9) Have no history of neither congenital nor chronic disease Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup) Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period Exclusion Criteria: Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc. Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs Have the following abnormal findings on diagnosis; have AST or ALT > 1.25 times of normal upper limit have total bilirubin > 1.5 times of normal upper limit have higher PT, aPPT, BT than normal range have PLT below 150,000 or above 350,000 Have been drug abuse, excessive caffeine (> 5 cups/day), heavy smoking (>10 cigarettes/day), continuous alcohol intake (> 30g/day) or have drunk within the last 7 days prior to the first administration Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration) Donated blood within 60 days prior to the first administration Participated in any other clinical trials within 60 days prior to the first administration Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration Subject who is judged to be ineligible by principal investigator or sub-investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Group A<br> | Drug: YH14659<br>* YH14659 capsule by oral<br>|
| Active Comparator: Group B<br> | Drug: clopidogrel & aspirin<br>* clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration(Cmax) of clopidogrel |  | 14 days | 
| Area under the time-concentration curve to last concentration(AUCt) of clopidogrel |  | 14 days | 
| Maximum plasma concentration(Cmax) of acetylsalicylic acid |  | 14 days | 
| Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of salicylic acid, the major active metabolite of aspirin |  | 14 days | 
| AUCt of salicylic acid, the major active metabolite of aspirin |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YH14659, Aspirin, Clopidogrel, Yuhan