Status:
COMPLETED
Comparative Pharmacokinetics of YH14659
Lead Sponsor:
Yuhan Corporation
Conditions:
Acute Coronary Syndrome
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01422109
Start Date
July 1 2011
End Date
December 1 2011
Last Update
January 9 2012
Active Locations (1)
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1
Yuhan Corporation
Seoul, South Korea, 156-754