Clinical trial NCT01761513: YH4808 Postprandial PK/PD Study in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
3. Subject who shows negative reaction of UBT(Urea Breath Test)
4. 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
5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
6. 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:

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. 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
3. 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)
4. Other exclusions apply

Primary outcomes:
measure: Area under the plasma concentration versus time curve of YH4808
timeFrame: Blood sampling during 0 ~ 24 hrs after administration
measure: Peak plasma concentration of YH4808
timeFrame: Blood sampling during 0~24 hrs after administration
Secondary outcomes:
measure: Time to reach peak plasma concentration of YH4808
timeFrame: Blood sampling during 0 ~ 24 hrs after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System(Severance Hospital)
state: Seodaemun-gu,Sinchon-dong
Study officials:
affiliation: Yonsei University Health System(Severance Hospital)
name: Minsoo Park, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.