A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000024460
- Lead Sponsor
- Adaptgen Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
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 appendectomy are excluded) 3)A person with a history of cerebrovascular disorder (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