Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

NCT ID: NCT01657071

Last Updated: 2012-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-04-30

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

• 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

• 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

Jang-Hee Hong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung-Nam National University Hospital

Locations

Yuhan Corporation

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YH14659-102

Identifier Type: -

Identifier Source: org_study_id