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Trial record 38 of 422 for:    CLARITHROMYCIN

The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects (YH4808-108)

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: NCT01921647
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE July 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: pre dose, 16 times after dosing ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48 h ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: pre dose, 16 times after dosing ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48h ]
  • gastric pH monitoring for 24hours [ Time Frame: 7:00 AM on Day 1 ~ 7:00 AM Day 2, 7:00 AM on Day 7 ~ 7:00 AM on Day 8 ]
  • the Ratio of Helicobacter pylori negative subject on Follow up visit [ Time Frame: D21~D25 after Investigational product administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Official Title  ICMJE The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Brief Summary The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin 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: Supportive Care
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: YH4808
    Other Name: experimental drug
  • Drug: Nexium
    Other Name: active comparator
  • Drug: Amoxicillin
    Other Name: experimental drug
  • Drug: clarithromycin
    Other Name: experimental drug
Study Arms  ICMJE
  • Experimental: YH4808, amoxicillin, clarithromycin
    single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
    Interventions:
    • Drug: YH4808
    • Drug: Amoxicillin
    • Drug: clarithromycin
  • Experimental: YH4808, amoxicillin and clarithromycin
    7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
    Interventions:
    • Drug: YH4808
    • Drug: Amoxicillin
    • Drug: clarithromycin
  • Experimental: YH4808 and amoxicillin
    7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
    Interventions:
    • Drug: YH4808
    • Drug: Amoxicillin
  • Active Comparator: nexium, amoxicillin and clarithromycin
    BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
    Interventions:
    • Drug: Nexium
    • Drug: Amoxicillin
    • Drug: clarithromycin
Publications *

*   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: December 2, 2013)
95
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
92
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
  2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  3. 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, 12-lead GCG etc)

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 symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
  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 NCT01921647
Other Study ID Numbers  ICMJE YH4808-108
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: Min soo Park, Ph.D, M.D. Severance Hospital
PRS Account Yuhan Corporation
Verification Date December 2013

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