A randomized, double-blind, placebo/active-controlled, single/multiple-dose, phase 1 clinical study to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of YH12852 after oral administration in healthy subjects

Yuhan0 个研究点目标入组 126 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1)healty male/female aged 19 to 45
•2)Subject who has body mass index(BMI) score within 18 and 25kg/m2
•3)Subject who has no congential, chronic disease and disease symptoms in medical examination result
•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, 12-lead ECG etc)
•5)Subject who has signed a written informed consent form 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

•1) Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery) within 2 years.
•2)Clinically significant abnormal values in dignostic check within 28 days before the treatment.
•3)Subject who is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs.
•4)Subject who participated in another clinical trail within 60 days before enrolling in this study.
•5)Subject who had taken any prescription drugs/herbal medicines within 2 weeks before the treatment or who had taken OTC drugs/vitamin within 2 weeks before the treatment.
•6)Subject who donated whole blood within 60 days or component blood within 30 days before the treatment.
•7)Medically unacceptable contraception used during the clinical trial.
•8)Subject who drank over 30g/day or were detected alcohol positive on test.
•9)Subject who stopped smoking within 3 months before the treatment or weren't able to stop smoking during the hospitalization.
•10)Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators.

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