Skip to main content
OpenTrials
Completed

NCT Number: NCT01761513

YH4808 Postprandial PK/PD Study in Healthy Subjects

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System(Severance Hospital)

Seoul, Seodaemun-gu,Sinchon-dong, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
  • Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
  • Subject who shows negative reaction of UBT(Urea Breath Test)
  • Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
  • Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
  • Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion criteria

  • Subject who is hypersensitive to components contained in YH4808 or this drug
  • Subject 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 has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
  • Other exclusions apply

Treatment and study plan

YH4808

Drug

Group1

  • adminitration of YH4808 dose1, bid for 2weeks
  • wash-out period for 3weeks between period1 and period2
  • adminitration of YH4808 dose2, qd for 2weeks

Primary outcomes

  1. Area under the plasma concentration versus time curve of YH4808

    Time frame: Blood sampling during 0 ~ 24 hrs after administration

  2. Peak plasma concentration of YH4808

    Time frame: Blood sampling during 0~24 hrs after administration

Secondary outcomes

  1. Time to reach peak plasma concentration of YH4808

    Time frame: Blood sampling during 0 ~ 24 hrs after administration

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
Apr 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.