A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310(1000/10mg) in healthy male volunteers

Inha University Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2019年3月25日

适应症

试验速览

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•1) Healthy male volunteer, age is over 19 years, under 45 years and Body weight is over 50kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2
•2) Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
•3) Subject who has the ability and willingness to participate the whole period of trial

•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)Subjects who are allergic to investigational drug.
•3)Subjects who have a medical history which can affect the clinical trial.
•4)Systolic BP = 150mmHg, BP =100mmHg or Diastolic BP= 95mmHg, BP = 55 mmHg
•5)AST(aspartate aminotransferase) or ALT(alanine aminotransaminase)> X 2 *UNL(upper normal limit)
•6)History of drug abuse or positive drug screening.
•7)Participation in other drug studies within 90 days prior to the drug administration.
•8)Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

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