A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers

Jeil Pharmaceutical0 个研究点目标入组 16 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 volunteer, age is 19 to 45 years.
•2.Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2
•3. A person who is determined to be eligible for the test through a physical examination or an interview conducted pursuant to this clinical trial plan. In other words, there is no congenital or chronic disease,
•4.Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test conducted according to this clinical trial plan.
•5. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial and 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.Low blood pressure(Systolic BP = 150mmHG or Diastolic BP = 95mmHg), Hypertension(Systolic BP = 100mmHG or Diastolic BP = 55mmHg)Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
•5.History of drug abuse or positive drug screening.
•6.Participation in other drug studies within 3 months prior to the drug administration.
•7.Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

发起方

Jeil Pharmaceutical