Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

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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A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects

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: Healthy male volunteers of aged between 20 years to 55 years Weight: over 50kg, within ±20% of ideal body weight 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 Subject who has signed on the written consent Exclusion Criteria: Have a known allergy or hypersensitivity to anti-platelet agents Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute 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 180,000 or above 350,000 Patients with hemorrhage or predisposition to hemorrhage Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs Have participated in other clinical studies within 3 months prior to the first administration Have used any prescription medications including anti-coagulants, anti-platelet agents, thrombolytic drugs and Prostaglandin E1 agents within 2 weeks prior to the first administration or any over-the-counter, non-prescription preparations within 1 week prior to the first administration Patients with aspirin induced asthma(AIA) or history of AIA 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 |
| --- | --- | --- |
| Cmax and AUCt of clopidogrel |  | 24hrs | 
| Cmax and AUCt of Acetylsalicylic acid |  | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid |  | 24hrs | 
| AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid |  | 24hrs |