A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Hanmi Pharm0 个研究点目标入组 38 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 male volunteer, age 19~50 years
•2.Weight =55kg and =90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
•3.Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
•4.Subjects who judged ineligible by the investigator.

•1.Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in liver, kidney, nervous system, respiratory system, endocrine system,blood dyscracia, neoplasm,cardiovascular system,genitourinary system or psychiatric system.
•2.Presence of medical history or a concurrent disease that may interfere with PK/PD evaluation of drugs including clinically significant disorders in Gastrointestinal tract
•3.Subject who has genetic problems (i.e galactose intolerance, Lapp lactose deficiency and glucose-galactose malabsorption etc)
•4.History of relevant drug allergies(i.e Tenofovir, Aspirin, Antibiotics etc) or clinically significant hypersesnsitivity reaction.

发起方

Hanmi Pharm