A dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, and pharmacokinetics of DWP09031 after oral administration in healthy male subjects

Inje University Busan Paik Hospital0 个研究点目标入组 64 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1)Healthy adult male subjects aged 20 to 45 years
•2)The subject has Broca's index = 20%
•3)A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
•4) A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

•1)A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
•2)A subject who shows vital signs with the number of systolic blood pressure of =141 mmHg or =89 mmHg, and the number of diastolic blood pressure of =91mmHg
•3) A subject who shows the following result in clinical laboratory test:
•AST,ALT>1.25 times of the upper limit of normal range
•PR = 210 msec
•QRS = 120 msec
•QT = 500 msec
•QTcF = 450 msec
•creatinine clearance = 80mL/min
•4)Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).

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