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Bioavailability and Pharmacodynamic study (phase1) of Disgren EC capsule(Triflusal 300mg)

Status Approved

  • First Submitted Date

    2014/11/20

  • Registered Date

    2014/12/05

  • Last Updated Date

    2014/12/05

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0001299
    Unique Protocol ID MI-04-02
    Public/Brief Title Bioavailability and Pharmacodynamic study of Disgren EC capsule(Triflusal 300mg)
    Scientific Title Bioavailability and Pharmacodynamic study (phase1) of Disgren EC capsule(Triflusal 300mg)
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNUH_07-0047
    Approval Date 2007-11-19
    Institutional Review Board Name Kyungpook National University Hospital Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young-Ran Yoon
    Title Professor
    Telephone +82-53-420-4950
    Affiliation Kyungpook National University Hospital
    Address
    Contact Person for Public Queries
    Name Young-Ran Yoon
    Title Professor
    Telephone +82-53-420-4950
    Affiliation Kyungpook National University Hospital
    Address
    Contact Person for Updating Information
    Name Young-Ran Yoon
    Title Professor
    Telephone +82-53-420-4950
    Affiliation Kyungpook National University Hospital
    Address
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2008-09-19 Actual
    Target Number of Participant 38
    Primary Completion Date 2008-10-25 , Actual
    Study Completion Date 2008-11-04 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kyungpook National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2008-09-19 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Myungin Pharm
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyungpook National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    A randomized, open-label, multiple-dose, two-period, two-treatment, comparative crossover study involving 38 healthy adult males. 
    The clinical trial was to determine the bioequivalence and non-inferiority of two different triflusal formulations. During each period, each subject received a single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Basic Science
    Phase Phase1
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    Triflusal capsule (Disgren capsule, 300 mg), as the reference formulation, and triflusal EC capsule (Disgren enteric-coated capsule, 300 mg), as the test formulation were manufactured and provided by Myung-In Pharm. Co., Ltd (Seoul, Republic of Korea). The subjects received the test or reference formulation in multiple doses, followed by a 13-day washout period and subsequent administration of the alternative formulation. During each period, each subject received a single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9.
    Number of Arms 2
    Arm 1

    Arm Label

    Group 1

    Target Number of Participant

    19

    Arm Type

    Others

    Arm Description

    For period 1, each subject received Disgren capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. For period 2, each subject received Disgren enteric-coated capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9.
    Arm 2

    Arm Label

    Group 2

    Target Number of Participant

    19

    Arm Type

    Others

    Arm Description

    For period 1, each subject received Disgren enteric-coated capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9. For period 2, each subject received Disgren capsule as single 900 mg oral loading dose on Day 1, followed by a 600 mg/day maintenance dose (given as two 300 mg capsules once daily) from Day 2 to 9.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    20Year~55Year

    Description

    •Healthy male subjects between the ages of 20 and 55 years at screening; 
    •No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment;
    •Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis, etc.);
    •Hemorrhagic tendencies from medical history.
    Exclusion Criteria
    •Use of barbital drugs or alcohol abuse within 1 month prior to the study initiation; 
    •Use of drugs disrupting this study  within 10 days prior to the study initiation; 
    •Medical history of clinically significant hypersensitivity to study drug; 
    •Subject that is not eligible to participate at this study, based on discretion of study investigator; 
    •Smoker; 
    •Clinical abnormalities at clinical laboratory test.
      - The levels of aspartate aminotransferase (serum glutamic oxaloacetic transaminase) or alanine aminotransferase (serum glutamic pyruvic transaminase) > 1.25 x the upper limit of normal
      - The levels of Total bilirubin > 1.25 x the upper limit of normal
      - Platelet count(<180,000 or >350,000)
      - prothrombin time (PT), activated partial thromboplastin time (aPTT) , and bleeding time (BT) > normal
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome &Pharmacokinetics/dynamics
    Primary Outcome(s) 1
    Outcome
    AUC(area under the concentration-time curve)
    Timepoint
    pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 192.5, 193, 194, 196, 199, 202, 216 h 
    Primary Outcome(s) 2
    Outcome
    Emax
    Timepoint
    pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 196, 202, 216 h 
    Secondary Outcome(s) 1
    Outcome
    Tmax(the time of Cmax)
    Timepoint
    pre-dose(0), post-dose 24, 48, 96, 144, 168, 192, 192.5, 193, 194, 196, 199, 202, 216 h 
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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