Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Acute Coronary Syndrome

Treatments: Drug: clopidogrel & aspirin; Drug: YH14659

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657071

YH14659-102

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: 60 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A

Experimental group

Treatment:

Drug: YH14659

Group B

Active Comparator group

Treatment:

Drug: clopidogrel & aspirin