Healthy
Conditions
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
Interventions
DRUGYH4808
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
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to reach peak plasma concentration of YH4808 | Blood sampling during 0 ~ 24 hrs after administration |
Countries
South Korea
Outcome results
None listed