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YH4808 Postprandial PK/PD Study in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761513
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date April 15, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Area under the plasma concentration versus time curve of YH4808 [ Time Frame: Blood sampling during 0 ~ 24 hrs after administration ]
  • Peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 0~24 hrs after administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Time to reach peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 0 ~ 24 hrs after administration ]
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 YH4808 Postprandial PK/PD Study in Healthy Subjects
Official Title  ICMJE A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers
Brief Summary A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy 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 Healthy
Intervention  ICMJE
  • Drug: YH4808

    Group1

    1. adminitration of YH4808 dose1, bid for 2weeks
    2. wash-out period for 3weeks between period1 and period2
    3. adminitration of YH4808 dose2, qd for 2weeks
  • Drug: YH4808

    Group2

    1. adminitration of YH4808 dose2, qd for 2weeks
    2. wash-out period for 3weeks between period1 and period2
    3. adminitration of YH4808 dose1, bid for 2weeks
  • Drug: YH4808

    Group3

    1. adminitration of YH4808 dose2, bid for 2weeks
    2. wash-out period for 3weeks between period1 and period2
    3. adminitration of Nexium tab 40mg, bid for 2weeks
    Other Name: YH4808, Nexium
  • Drug: YH4808

    Group 4

    1. adminitration of Nexium tab 40mg, bid for 2weeks
    2. wash-out period for 3weeks between period1 and period2
    3. adminitration of YH4808 dose2, bid for 2weeks
    Other Name: Nexium
Study Arms  ICMJE
  • Experimental: Sequence 1
    Interventions:
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
  • Experimental: Sequence 2
    Interventions:
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
  • Active Comparator: Sequence 3
    Interventions:
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
  • Active Comparator: Sequence 4
    Interventions:
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
    • Drug: YH4808
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: April 14, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
20
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
  2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
  3. Subject who shows negative reaction of UBT(Urea Breath Test)
  4. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
  5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
  6. Volunteers who has signed a written informed consent voluntarily, prior to 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

Exclusion Criteria:

  1. Subject who is hypersensitive to components contained in YH4808 or this drug
  2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
  3. Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
  4. Other exclusions apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT01761513
Other Study ID Numbers  ICMJE YH4808-107
Has Data Monitoring Committee No
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: Minsoo Park, Ph.D, M.D. Yonsei University Health System(Severance Hospital)
PRS Account Yuhan Corporation
Verification Date April 2014

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