JPRN-UMIN000025376Completed未知
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.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Kowa Company, Ltd.
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 45years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Investigators
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