Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01657071
First received: March 21, 2012
Last updated: August 2, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Drug: YH14659
Drug: clopidogrel & aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Cmax and AUCt of clopidogrel [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
  • Cmax and AUCt of Acetylsalicylic acid [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • AUCt, Cmax, Tmax, T1/2, λz and AUC∞ of salicylic acid [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: YH14659
YH14659 capsule by oral
Active Comparator: Group B Drug: clopidogrel & aspirin
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657071

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of, 156-754
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Jang-Hee Hong, M.D., Ph.D. Chung-Nam National University Hospital
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01657071     History of Changes
Other Study ID Numbers: YH14659-102
Study First Received: March 21, 2012
Last Updated: August 2, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on August 26, 2014