Single Blind, Placebo-Controlled Study of Acetaminophen for Liver function in Healthy Japanese Adults - Study of Acetaminophen on Shift of Liver Function Markers

Kitasato Clinical Trial Center0 个研究点目标入组 240 人开始时间: 2015年11月18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 enrollment by the following criteria. The investigator must ensure the criteria basically at the timing of screening. 1) Any subject with a past history of anaphylaxis due to acetaminophen. 2) Any subject with peptic ulcer. 3) Any subject with blood abnormality, hepatopathy, kidney damage or cardiac dysfunction. 4) Aspirin-induced asthma or a history of diseases of aspirin-induced asthma. 5) Alcohol drinkers (daily alcohol intake of 30 g or more in the past 3 months). 6) Use of any medicine, energy drink and health food product containing Saint John's wort or use of a drug within 14 days before study drug administration. 7) Participation in any other clinical trial within the past 12 weeks. 8) Persons who have donated more than 200 ml of blood in the past 4 weeks or more than 400 ml of blood in the past 12 weeks (more than 200 ml of blood in the past 4 weeks or more than 400 ml of blood in the past 16 weeks in female). 9) Any subject with a positive serological response for syphilis, HIV antigen or antibody, HBs antigen, or HCV antibody. 10) Any subject have drug or food allergies. 11) Any subject known to abuse drugs or who tests positive for a drug in urine screening tests. 12) Women who are pregnant, maybe pregnant or lactation. 13) Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.

发起方

Kitasato Clinical Trial Center