Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: YH14659; Drug: clopidogrel & aspirin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-754
    • Yuhan Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: YH14659; YH14659 capsule by oral
Active Comparator: Group B	Drug: clopidogrel & aspirin; clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax and AUCt of clopidogrel	24hrs
Cmax and AUCt of Acetylsalicylic acid	24hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid	24hrs
AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid	24hrs

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Jang-Hee Hong, M.D., Ph.D., Chung-Nam National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): August 3, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: YH14659-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No