Acute Coronary Syndrome
Conditions
Keywords
YH14659, Aspirin, Clopidogrel, Yuhan
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
* 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| AUCt of salicylic acid, the major active metabolite of aspirin | 14 days |
| Cmax of salicylic acid, the major active metabolite of aspirin | 14 days |
Countries
South Korea
Outcome results
None listed