Comparative Pharmacokinetics of YH14659

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01422109
First received: August 16, 2011
Last updated: January 5, 2012
Last verified: January 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: Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Maximum plasma concentration(Cmax) of clopidogrel [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Area under the time-concentration curve to last concentration(AUCt) of clopidogrel [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Maximum plasma concentration(Cmax) of acetylsalicylic acid [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of salicylic acid, the major active metabolite of aspirin [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • AUCt of salicylic acid, the major active metabolite of aspirin [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (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:

  • The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
  • Healthy male volunteers of aged between 20 years to 55 years
  • Have standard weight of ≤ ±20% based on Broca index* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
  • 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

Exclusion Criteria:

  • Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
  • Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
  • Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
  • Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
  • Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
  • 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 150,000 or above 350,000
  • Have been drug abuse, excessive caffeine (> 5 cups/day), heavy smoking (>10 cigarettes/day), continuous alcohol intake (> 30g/day) or have drunk within the last 7 days prior to the first administration
  • Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
  • Donated blood within 60 days prior to the first administration
  • Participated in any other clinical trials within 60 days prior to the first administration
  • Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
  • 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: NCT01422109

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of, 156-754
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Jae-Gook Shin, MD, PhD. Inje University
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01422109     History of Changes
Other Study ID Numbers: YH14659-101
Study First Received: August 16, 2011
Last Updated: January 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
YH14659
Aspirin
Clopidogrel
Yuhan

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 20, 2014