A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects.

Yuhan0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•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.

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