Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Aspirin; Clopidogrel

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