Acute Coronary Syndrome
Conditions
Brief summary
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.
Interventions
DRUGYH14659
YH14659 capsule by oral
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUCt of clopidogrel | 24hrs |
| Cmax and AUCt of Acetylsalicylic acid | 24hrs |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed