A clinical study for evaluating safety of long-term consumption -Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults. - A clinical study for evaluating safety of long-term consumption -Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.

Kowa Company, Ltd.0 sites10 target enrollmentJanuary 23, 2017

Overview

No summary available.

Registry

who.int

Start Date

January 23, 2017

End Date

May 20, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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