A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults. - A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.

Kowa Company, Ltd.0 个研究点目标入组 10 人开始时间: 2017年1月23日最近更新: 2023年10月17日

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•The following exclusion criteria apply to subjects. 1) A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food 2) A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the a ppendectomy are excluded) 3) A person with a history of cerebrovasculardisorder (the asymptomatic lacunar infarct is excluded) 4) A person with tattoo which has an influence on the study because of its size or range 5) A person with hypersensitivity or idiosyncrasy, such as food allergy 6) A person who is suspected to have alcohol or drug dependence 7) A person who has participated in other clinical trials within 84 days from giving an informed consent 8) A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent 9) A person who hopes pregnancy or who cannot prevent conception during the study 10) A nursing or pregnant woman 11) A person who is engaged in night duty

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