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CompletedNCT01876615Updated Jan 1, 2014

Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

A Phase 1 interventional study of YH4808 and Diclofenac in Healthy, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-01.

Sponsored by Yuhan Corporation · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • safety/tolerability and pharmacokinetics/pharmacodynamics
03

In context

Lead sponsor

Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • 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 · Drug: Diclofenac · 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 · Drug: Diclofenac · 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 · Drug: Diclofenac · 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 · Drug: Diclofenac · 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 · Drug: Diclofenac · 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 · Drug: Diclofenac · Drug: YH4808+Diclofenac

Interventions

  • DrugYH4808

    experimental drug

  • DrugDiclofenac

    Depain tablet 25mg

    Also known as: Depain tablet 25mg

  • DrugYH4808+Diclofenac
06

What researchers measure

Primary outcomes

  1. Cmax of YH4808

    Time frame: 18 points up to Day 2 or Day 3

  2. AUClast of YH4808

    Time frame: 18 points up to Day 3

Secondary outcomes

  1. AUCinf of YH4808

    Time frame: 18 points up to Day 3

  2. AUCinf of Diclofenac

    Time frame: 16points up to Day 2

  3. t1/2 of YH4808

    Time frame: 18 points up to Day 3

  4. t1/2 of Diclofenac

    Time frame: 16 points up to Day 2

  5. Tmax of YH4808

    Time frame: 18 points up to Day 3

  6. Tmax of Diclofenac

    Time frame: 16 points up to Day 2

  7. Metabolic ratio

    Time frame: 18 points up to Day 3

07

Study locations

1 site
  • Chungnam National University Hospital
    Daejeon, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01876615
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Jun 12, 2013
Start date
Jul 2013
Primary completion
Oct 2013
Completion
Dec 2013
Last update
Jan 1, 2014

Study contacts

Janghee Hong, Professor
principal investigator · Chungnam National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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