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Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
G0041(75/100mg)
Clopidogrel & Aspirin
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Clopidogrel, Aspirin, coadministration

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy male volunteers between the ages of 20 to 50 years old
  • weight more than 55kg and within the range of ±20% of IBW
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

  • Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
  • Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣
  • Creatinine clearance < 80 mL/min
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
  • Excessive drinking(exceed 21units/week)
  • Smoking over 10 cigarettes per day

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    G0041(75/100mg)

    Clopidogrel & Aspirin

    Arm Description

    Outcomes

    Primary Outcome Measures

    C(max) of Clopidogrel
    AUC(last) of Clopidogrel
    C(max) of Acetylsalicylic acid
    AUC(last) of Acetylsalicylic acid

    Secondary Outcome Measures

    C(max) of Salicylic acid
    AUC(last) of Salicylic acid

    Full Information

    First Posted
    January 11, 2012
    Last Updated
    September 29, 2014
    Sponsor
    Dong-A ST Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01526122
    Brief Title
    Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
    Official Title
    A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dong-A ST Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules coadministration in healthy male volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis
    Keywords
    Clopidogrel, Aspirin, coadministration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    G0041(75/100mg)
    Arm Type
    Experimental
    Arm Title
    Clopidogrel & Aspirin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    G0041(75/100mg)
    Intervention Description
    G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel & Aspirin
    Intervention Description
    Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO
    Primary Outcome Measure Information:
    Title
    C(max) of Clopidogrel
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
    Title
    AUC(last) of Clopidogrel
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
    Title
    C(max) of Acetylsalicylic acid
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
    Title
    AUC(last) of Acetylsalicylic acid
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
    Secondary Outcome Measure Information:
    Title
    C(max) of Salicylic acid
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
    Title
    AUC(last) of Salicylic acid
    Time Frame
    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy male volunteers between the ages of 20 to 50 years old weight more than 55kg and within the range of ±20% of IBW having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination doctor determines to be suitable as subjects within 3 weeks ago before administration Exclusion Criteria: Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣ Creatinine clearance < 80 mL/min Gastrointestinal diseases or surgeries that affect absorption of drug Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption Excessive drinking(exceed 21units/week) Smoking over 10 cigarettes per day
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young-ran Yoon, M.D., Ph.D.
    Organizational Affiliation
    Kyungpook National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20171421
    Citation
    Di Girolamo G, Czerniuk P, Bertuola R, Keller GA. Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2010 Jan;32(1):161-70. doi: 10.1016/j.clinthera.2010.01.010.
    Results Reference
    background
    PubMed Identifier
    18254152
    Citation
    Bae SK, Seo KA, Jung EJ, Kim HS, Yeo CW, Shon JH, Park KM, Liu KH, Shin JG. Determination of acetylsalicylic acid and its major metabolite, salicylic acid, in human plasma using liquid chromatography-tandem mass spectrometry: application to pharmacokinetic study of Astrix in Korean healthy volunteers. Biomed Chromatogr. 2008 Jun;22(6):590-5. doi: 10.1002/bmc.973.
    Results Reference
    background
    PubMed Identifier
    19446152
    Citation
    Kim SD, Kang W, Lee HW, Park DJ, Ahn JH, Kim MJ, Kim EY, Kim SW, Nam HS, Na HJ, Yoon YR. Bioequivalence and tolerability of two clopidogrel salt preparations, besylate and bisulfate: a randomized, open-label, crossover study in healthy Korean male subjects. Clin Ther. 2009 Apr;31(4):793-803. doi: 10.1016/j.clinthera.2009.04.017.
    Results Reference
    background
    Citation
    EMEA(2009), CHMP assessment report of DuoCover. EMEA/H/C/001144
    Results Reference
    background

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    Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

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