Comparative Pharmacokinetics of YH14659

Yuhan

Status and phase

Completed

Phase 1

Conditions

Acute Coronary Syndrome

Treatments

Drug: clopidogrel & aspirin

Drug: YH14659

Study type

Interventional

Funder types

Industry

Identifiers

NCT01422109

YH14659-101

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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