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Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657071
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
Yuhan Corporation

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: YH14659 Drug: clopidogrel & aspirin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Cmax and AUCt of clopidogrel [ Time Frame: 24hrs ]
  2. Cmax and AUCt of Acetylsalicylic acid [ Time Frame: 24hrs ]

Secondary Outcome Measures :
  1. Tmax, T1/2, λz and AUC∞ of Clopidogrel and Acetylsalicylic acid - AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid [ Time Frame: 24hrs ]
  2. AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid [ Time Frame: 24hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657071

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Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of, 156-754
Sponsors and Collaborators
Yuhan Corporation
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Principal Investigator: Jang-Hee Hong, M.D., Ph.D. Chung-Nam National University Hospital
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Responsible Party: Yuhan Corporation Identifier: NCT01657071    
Other Study ID Numbers: YH14659-102
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents