YH4808 Postprandial PK/PD Study in Healthy Subjects
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
1 other identifier
interventional
21
1 country
1
Brief Summary
A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Nov 2012
Longer than P75 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
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedApril 15, 2014
April 1, 2014
3 months
January 2, 2013
April 14, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the plasma concentration versus time curve of YH4808
Blood sampling during 0 ~ 24 hrs after administration
Peak plasma concentration of YH4808
Blood sampling during 0~24 hrs after administration
Secondary Outcomes (1)
Time to reach peak plasma concentration of YH4808
Blood sampling during 0 ~ 24 hrs after administration
Study Arms (4)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALSequence 3
ACTIVE COMPARATORSequence 4
ACTIVE COMPARATORInterventions
Group1 1. adminitration of YH4808 dose1, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, qd for 2weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System(Severance Hospital)
Seoul, Seodaemun-gu,Sinchon-dong, 120-752, South Korea
Related Publications (1)
Yoon S, Oh E, Park MS, Jang SB, Byun HM, Park H, Kim H, Kim CO. Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen. Transl Clin Pharmacol. 2021 Sep;29(3):150-159. doi: 10.12793/tcp.2021.29.e15. Epub 2021 Sep 17.
PMID: 34621707DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minsoo Park, Ph.D, M.D.
Yonsei University Health System(Severance Hospital)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 4, 2013
Study Start
November 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2014
Last Updated
April 15, 2014
Record last verified: 2014-04