An open-label, multiple oral dose study to explore the pharmacokinetic and pharmacodynamic profiles of 0.5mg colchicine in healthy male adult volunteers - PK/ PD study of Colchicine-1

Clinical Trial Center, Kitasato University Hospital0 个研究点目标入组 8 人开始时间: 2015年6月23日最近更新: 2023年10月17日

适应症

试验速览

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•Subjects will be excluded from the study by the following criteria. The investigator must ensure the criteria basically at the screening visit. 1 Subjects who have history of hypersensitivity to Colchicine, Heparin and Fat emulsion 2 Subjects who are contraindicated to the use of Colchicine, Heparin and Fat emulsion 3 Subjects with haptic and renal dysfunction that needs any treatments 4 Subjects with diseases or conditions that are assumed to be adversely affected by pharmacological effects of Colchicine, Heparin and Fat emulsion 5 Subjects took any drug or health food containing St Johns wort within 7 days before dosing and be judged not eligible for the enrollment of the study by the investigator 6 Subjects who took food and drink containing grapefruits 7 days prior to dosing 7 Subjects who participated any clinical trials within 3 months before the enrollment 8 Subjects who donated 200ml of blood within a month or 400ml within 3 months 9 Subjects who showed positive results of Syphilis test, Hepatitis B surface antigen or Hepatitis C 10 Subjects who had history of drug or alcohol abuse or who showed evidence of such abuse by the laboratory test at the screening 11 Subjects whom the investigator consider ineligible for the study

发起方

Clinical Trial Center, Kitasato University Hospital