Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

NCT ID: NCT01876615

Last Updated: 2014-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-12-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

YH4808

Intervention Type: DRUG

experimental drug

Diclofenac

Intervention Type: DRUG

Depain tablet 25mg

YH4808+Diclofenac

Intervention Type: DRUG

Interventions

YH4808

experimental drug

Intervention Type: DRUG

Diclofenac

Depain tablet 25mg

Intervention Type: DRUG

YH4808+Diclofenac

Intervention Type: DRUG

Other Intervention Names

Depain tablet 25mg

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janghee Hong, Professor

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

YH4808-109

Identifier Type: -

Identifier Source: org_study_id