Clinical trial NCT01876615: Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 49
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Cmax of YH4808
timeFrame: 18 points up to Day 2 or Day 3
measure: AUClast of YH4808
timeFrame: 18 points up to Day 3
Secondary outcomes:
measure: AUCinf of YH4808
timeFrame: 18 points up to Day 3
measure: AUCinf of Diclofenac
timeFrame: 16points up to Day 2
measure: t1/2 of YH4808
timeFrame: 18 points up to Day 3
measure: t1/2 of Diclofenac
timeFrame: 16 points up to Day 2
measure: Tmax of YH4808
timeFrame: 18 points up to Day 3
measure: Tmax of Diclofenac
timeFrame: 16 points up to Day 2
measure: Metabolic ratio
timeFrame: 18 points up to Day 3
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University Hospital
name: Janghee Hong, Professor
role: PRINCIPAL_INVESTIGATOR
References: