Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac
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
1 other identifier
interventional
49
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2013
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 1, 2014
December 1, 2013
3 months
June 10, 2013
December 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax of YH4808
18 points up to Day 2 or Day 3
AUClast of YH4808
18 points up to Day 3
Secondary Outcomes (7)
AUCinf of YH4808
18 points up to Day 3
AUCinf of Diclofenac
16points up to Day 2
t1/2 of YH4808
18 points up to Day 3
t1/2 of Diclofenac
16 points up to Day 2
Tmax of YH4808
18 points up to Day 3
- +2 more secondary outcomes
Study Arms (6)
YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
YH4808 or Diclofenac or YH4808+Diclofenac (arm5)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
YH4808 or Diclofenac or YH4808+Diclofenac (arm6)
EXPERIMENTAL6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Interventions
experimental drug
Depain tablet 25mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam National University Hospital
Daejeon, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janghee Hong, Professor
Chungnam National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
January 1, 2014
Record last verified: 2013-12