A randomized, open-label, single dose, 3-way crossover clinical trial to investigate the effect of food on the pharmacokinetics of HSG4112 in healthy male volunteers

Seoul National University Hospital0 个研究点目标入组 12 人开始时间: 待定最近更新: 2022年1月11日

试验速览

暂无简介。

•1)Subjects who voluntarily agreed to participate in this study and singed the written informed consent form approved by the IRB, after fully listening to and understanding the details of this study before screening
•2)Healthy adult male subjects aged 19 to 50 years at the time of screening
•3)Subjects with a body mass index (BMI) within a range of 18.0 kg/m2 to 27.0 kg/m2
•?BMI, kg/m2 = weight(kg)/[height(m)2]
•4)Subjects in good health, determined by no clinically significant findings from medical history, physical examination, vital sign measurements, 12-lead ECG and clinical laboratory tests (Subjects with results that are not within the normal range may still participate with the approval of the Investigator)

•1)Subjects with clinically significant history or manifestation of any hepatic, renal, nerve, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, or psychiatric disorder (mood disorder, obsessive compulsive disorder, etc.)
•2)Subjects with a history of any gastrointestinal disorder (e.g., Crohn’s disease, ulcer) or surgery (not including simple appendectomy, hemorrhoidectomy, and hernia surgery) which may affect the safety and pharmacokinetic assessment
•3)Subjects with a history of clinically significant hypersensitivity to drugs including liquorice or other drugs (e.g., aspirin, antibiotics)
•4)Subjects who showed one or more of the following clinical laboratory test results at screening:
•-ALT (SGPT) > 60 IU/L
•-Fasting glucose level > 110 mg/dL or <70 mg/dL
•-Testosterone < 2.49 ng/mL or > 8.36 ng/mL
•5)Subjects with a systolic blood pressure of < 90 mmHg or > 150 mmHg, diastolic blood pressure of < 60 mmHg or >100 mmHg after at least 3 minutes in sitting position

发起方