Comparative Pharmacokinetics of YH14659

NCT ID: NCT01422109

Last Updated: 2012-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

YH14659

Intervention Type: DRUG

YH14659 capsule by oral

Group B

Group Type: ACTIVE_COMPARATOR

clopidogrel & aspirin

Intervention Type: DRUG

clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

Interventions

YH14659

YH14659 capsule by oral

Intervention Type: DRUG

clopidogrel & aspirin

clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae-Gook Shin, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

Yuhan Corporation

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YH14659-101

Identifier Type: -

Identifier Source: org_study_id