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
- Healthy adults
- Registration Number
- JPRN-UMIN000025376
- Lead Sponsor
- Kowa Company, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Appearance of adverse events -Height, weight and BMI -Body temperature, blood pressure and pulse -12-lead electrocardiogram -General hematology test -Blood biochemistry test -Urinalysis
- Secondary Outcome Measures
Name Time Method