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Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

Sponsor
Yuhan Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01876615
Collaborator
(none)
49
Enrollment
1
Location
6
Arms
5
Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Randomized, Open-Label, Single-dosing and Cross-over Clinical Trial to Investigate the Safety and Pharmacokinetic Drug-Drug Interaction of YH4808 and Diclofenac in Healthy Male Volunteers
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)

6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

Drug: YH4808
experimental drug

Drug: Diclofenac
Depain tablet 25mg
Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac
    Experimental: YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)

    6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

    Drug: YH4808
    experimental drug

    Drug: Diclofenac
    Depain tablet 25mg
    Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac
    Experimental: YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)

    6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

    Drug: YH4808
    experimental drug

    Drug: Diclofenac
    Depain tablet 25mg
    Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac
    Experimental: YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)

    6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

    Drug: YH4808
    experimental drug

    Drug: Diclofenac
    Depain tablet 25mg
    Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac
    Experimental: YH4808 or Diclofenac or YH4808+Diclofenac (arm5)

    6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

    Drug: YH4808
    experimental drug

    Drug: Diclofenac
    Depain tablet 25mg
    Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac
    Experimental: YH4808 or Diclofenac or YH4808+Diclofenac (arm6)

    6 arm, 3 Sequence design YH4808 or Diclofenac or YH4808+Diclofenac 3 week wash out period is between each period.

    Drug: YH4808
    experimental drug

    Drug: Diclofenac
    Depain tablet 25mg
    Other Names:
  • Depain tablet 25mg

    • Drug: YH4808+Diclofenac

    Outcome Measures

    Primary Outcome Measures

    1. Cmax of YH4808 [18 points up to Day 2 or Day 3]

    2. AUClast of YH4808 [18 points up to Day 3]

    Secondary Outcome Measures

    1. AUCinf of YH4808 [18 points up to Day 3]

    2. AUCinf of Diclofenac [16points up to Day 2]

    3. t1/2 of YH4808 [18 points up to Day 3]

    4. t1/2 of Diclofenac [16 points up to Day 2]

    5. Tmax of YH4808 [18 points up to Day 3]

    6. Tmax of Diclofenac [16 points up to Day 2]

    7. Metabolic ratio [18 points up to Day 3]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • healthy male age 20 to 45 over 55kg with Ideal body weight(IBW)

    • No clinically important abnormal physical findings at the screening examination

    • Subject who has no congential, chronic disease and disease symptoms in medical examination result

    • Subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons includiong ther abnorminal test results(clinical laboratory test, 12-lead GCG etc)

    • Ability to communicate well with the inverstigator and to comply with the requremetns of the entire study

    • Willingness to give written informed consent(prior to any study-related procedures beinging performed) and to be able to adhere to the study restrictions and examination schedule

    Exclusion Criteria:

    • Suject 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

    • Subject who is hypersensitive to components contained in YH4808 or declofenac or related drug(ex. rebamipide, revaprazan, NSID etc)

    • Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)

    • Subject who has history of drug dependence or using that drug

    • Subject who had taken usual dose of any prescription durgs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment

    • Subject who participated in antoher clinical trial within 2 monthes before enrolling in this study

    • subject who donated whole blood within 2 months or component blood within 1 month before the treatment

    • Subject who drank over 21unit/week(1 unit= 10g of alcohol) or were not able to refrain from drinking alcohol during study days

    • Subject who stopped smoking within 3 months before the treatment or detected cotinine in urine test

    • Subject with clinically significant observations considered as unsuitable based on medical judgment by the investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungnam National University Hospital Daejeon Korea, Republic of

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    • Principal Investigator: Janghee Hong, Professor, Chungnam National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT01876615
    Other Study ID Numbers:
    • YH4808-109
    First Posted:
    Jun 12, 2013
    Last Update Posted:
    Jan 1, 2014
    Last Verified:
    Dec 1, 2013
    Keywords provided by Yuhan Corporation
    safety/tolerability and pharmacokinetics/pharmacodynamics
    Additional relevant MeSH terms:
    Diclofenac

    Study Results

    No Results Posted as of Jan 1, 2014