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Comparative Pharmacokinetics of YH14659 (YH14659)

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ClinicalTrials.gov Identifier: NCT01422109
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE August 23, 2011
Last Update Posted Date January 9, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2011)
  • Maximum plasma concentration(Cmax) of clopidogrel [ Time Frame: 14 days ]
  • Area under the time-concentration curve to last concentration(AUCt) of clopidogrel [ Time Frame: 14 days ]
  • Maximum plasma concentration(Cmax) of acetylsalicylic acid [ Time Frame: 14 days ]
  • Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01422109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2011)
  • Cmax of salicylic acid, the major active metabolite of aspirin [ Time Frame: 14 days ]
  • AUCt of salicylic acid, the major active metabolite of aspirin [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Pharmacokinetics of YH14659
Official Title  ICMJE Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: YH14659
    YH14659 capsule by oral
  • Drug: clopidogrel & aspirin
    clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Drug: YH14659
  • Active Comparator: Group B
    Intervention: Drug: clopidogrel & aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2011)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01422109
Other Study ID Numbers  ICMJE YH14659-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuhan Corporation
Study Sponsor  ICMJE Yuhan Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Gook Shin, MD, PhD. Inje University
PRS Account Yuhan Corporation
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP