Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects - FMU-DF-001

Fukushima Medical University Clinical Oncology Center, Division of Pediatric Oncology, Atsushi Kikuta0 个研究点目标入组 20 人开始时间: 2013年1月10日最近更新: 2023年10月17日

适应症

试验速览

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•1.History of abnormal function in CNS, cardiovascular system, respiratory sytem, blood/hematopoietic system, gastroenteric system, liver/kidney, thyroid, pituitary gland, adrenal gland and so on and it is difficult to keep safety of subjects during clinical study. 2.Known hypersensitivity to some drugs 3.Abuse of alcohol or drugs 4.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 5.History of blood taken *>=1200ml of all blood within 1 year before screening *>=400ml of all blood with 84 days before screening *>=200ml of all blood within 28 days before screening *taken blood component within 14 days *taken all blood or blood component after screening and before clinical laboratory tests at entering in hospital 6. Treatment with any investigational compound within 120 days before screening or after screening 7. Treatment by other doctors within 28 days before the dose of study drug 8. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.

发起方

Fukushima Medical University Clinical Oncology Center, Division of Pediatric Oncology, Atsushi Kikuta