A Double-blind, Randomized, Placebo-controlled Intervention Study of the Efficacy and Safety of ID1216 in the Overweight Subject

Ildong pharmaceutical0 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

试验速览

暂无简介。

•1) Male and female subjects between 20-60years of age inclusive.
•2) BMI of 25.0-29.9kg/m2
•3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

•1)Clinically significant abnormality reaction in the history of investigational drugs or health functional food.
•2)Have a gastrointestinal disease history that can affect drug absorption (Crohn’s disease) or surgery (except simple appendectomy or hernia surgery)
•3)Defined by the following laboratory parameters:
•- AST, ALT = 2 times the upper limit of normal.
•4)Defined by the following clinical disease:
•-Subjects who use of beta blocker or hydragogue
•-Subjects with diabetes (use of hypoglycemic agent or insulin)
•-Subjects with endocrinopathy or abnormal screening TSH value
•-Subjects with medical conditions, including depression, schizophrenia, psychosis, alcohol abuse and drug abuse
•-Subjects with clinically significant cardiovascular disease (heart failure, angina pectoris, myocardial infarction, etc.)
•-Subjects with clinically significant liver disease (Hepatitis B, Hepatitis C, Liver cancer, etc.)
•5)Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
•6)Woman who are pregnant or lactating.
•7)Subjects who are registered on the other clinical research within 1 month before enroll.
•8)An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

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