The exploration for pharmacodynamics and pharmacokinetics of YH4808 New formulation in healthy subjects
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001238
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1. healthy adult age 19 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. negative to Helicobacter pylori in 13C urea breath test
4. Subject who is judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first investigational product(IP) administration.
5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)
1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of investigational product(IP).
3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
4. pregnant or lactating woman.
5. Subject who is judged to be inappropriate for the clinical trial by investigator for any other reason.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-24h(AUCt,ss), Cmax(Cmax,ss) of YH4808 and M3(; active metabolite of YH4808);arithmatic mean and median of pH-values measured for 24hrs in stomach, and duration & proportion of the hours with pH-values over 4 and 5 in stomach for 24hrs
- Secondary Outcome Measures
Name Time Method AUC0-24h(AUCt,ss), Cmax(Cman,ss) of M8(; inactive metabolite of YH4808);Tmax(Tmax,ss) of YH4808, M3(active metabolite of YH4808), M8(inactive metabolite of YH4808);metabolic ratio of M3(active metabolite of YH4808) and M8(inactive metabolite of YH4808);T1/2, accumulation index(AI), Fluctuation(F) of YH4808, M3(active metabolite of YH4808), M8(inactive metabolite of YH4808)