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Completed

NCT Number: NCT01876615

Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

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

Completed

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital

Daejeon, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH4808

Drug

experimental drug

Diclofenac

Drug

Depain tablet 25mg

Other names: Depain tablet 25mg

YH4808+Diclofenac

Drug

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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2013
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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