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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; 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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; 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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; 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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; 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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; 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; experimental drug; Drug: Diclofenac; Depain tablet 25mg; Other Names: Depain tablet 25mg; Drug: YH4808+Diclofenac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of YH4808	18 points up to Day 2 or Day 3
AUClast of YH4808	18 points up to Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Tmax of Diclofenac	16 points up to Day 2
Metabolic ratio	18 points up to Day 3

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Janghee Hong, Professor, Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (ESTIMATE): June 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2014
• Last Update Submitted That Met QC Criteria: December 31, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: YH4808-109