on-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals
- Conditions
- Healthy person
- Registration Number
- JPRN-UMIN000019159
- Lead Sponsor
- Medical Fusion Co.,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)Use of any prescription drugs or any over-the-counter drugs from -7 day to -1 day before dosing. 2) A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion. 3) A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient. 4) A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded). 5) A person with tattoo. 6) A person with hypersensitivity or idiosyncrasy, such as food allergies. 7) A person with alcohol or drug dependency. 8) A person who has participated in other clinical trials within 84 days of giving informed consent. 9) A person who has donated 400 ml of blood within 84 days, 200 ml of blood within 28 days, or a blood component (plasma or platelets) within 14 days of giving informed consent. 10) A person trying to become pregnant within the clinical study period. 11) Unable or unwilling to use medically acceptable means of contraception. 12) Nursing or pregnant woman. 13) A person whose diagnosis requires treatment of mental illness by a clinical investigator. 14) A person who is unable to comply with administrative matters during the clinical study. 15) Other people, who are determined ineligible by the clinical investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events
- Secondary Outcome Measures
Name Time Method -Body mass index(BMI) -Blood pressure/pulse/body temperature -General blood test -Biochemical examination -Antioxidative effect and oxidative stress level -Urinalysis -12-lead electrocardiogram -Stool characteristics, stool frequency, stool output -Meal recording