Randomized, Open Label, multiple-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects

Hanmi Pharm0 个研究点目标入组 36 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1.Healthy male volunteers, age 20 to 55 years.
•2.The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
•3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

•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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
•2.Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
•3.Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
•4.Systolic blood pressure <90mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg(Sitting blood pressure) during the screening procedure.

发起方

Hanmi Pharm