A Randomized, Fed, Open-label, Crossover Clinical Study to compare Pharmacokinetics and Safety of WIP-DF17 for Single Dose in Healthy Adult Subjects.

Whan In Pharm0 个研究点目标入组 30 人开始时间: 待定最近更新: 2019年10月7日

适应症

试验速览

暂无简介。

•1) Healthy Adult Subject older than 19 to 45 years at the time of screening
•2) Subjects whose body weight is over 50kg and within Body Mass Index(BMI) 18.0~29.0 kg/m2(BMI = (weight [kg])/(height [m])23) Subjects without congenital/chronic disease or pathological symptoms/findings
•4) subjects suitable and involved in clinical trial by the attending physician to be eligible according to laboratory tests(included hematologic examination, blood chemistry test, urine test) based on the characteristics of the IP
•5) Subject who is not pregnant
•6) Subject who has no history of psychopathical disorder within 5 years before the screening.
•7) Subject who has no history of gastrectomy which can affect to drug absorption.
•8) Subject who volunteers to participate the clinical trials

•1) Subject who has taken the medicine inducing and suppressing drug metabolic enzyme, such as barbital drugs within 1 month before the Screening Visit.
•2) Subject who drinks excessively within 1 month before the Screening Visit.
•Male: > 21 drinks/week
•Female: > 14 drinks/week
•(1 drink: Soju 50mL, Beer 250mL, Liquor: 30mL)
•3) Subject who had taken the medicine which can affect the results of this study within 10 days before the Screening Visit
•4) Subject who judged unsuitable to participate in clinical trials by the Investigator.
•5) Subject who had participated in other clinical study or bioequivalence study within 90 days before the first administration day
•6) Subject who had donated whole blood within 60 days, donated component blood within 30 days, or received blood transfusion within 30 days before the Screening Visit.
•7) Subject who had taken any prescription drug or herbal medicine within 14 days or any Over The Counter within 7 days before the first administration. (Based on the investigator's judgment, if other conditions are appropriate, it is possible to participate in clinical trials)
•8) Subject whose AST/ALT in blood is exceeded over 2x or Gamma GT is exceeded over 1.5x compared to Reference Range.
•9) Subject who do not agree with the approved method of contraception during the Clinical Trial.
•10) Subject who is lactating women

发起方

Whan In Pharm