ong-term safety trial - Non-blinded safety verification test using a dose of the test food "FGPPY30" five times higher than that intended for healthy individuals
- Conditions
- Healthy person
- Registration Number
- JPRN-UMIN000020608
- 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. -Use of any drugs from -7 day to -1 day before dosing. -A person who have used the steroid drug within the past three months of consent acquisition date. -A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion. -A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient. -A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded). -A person with tattoo. -A person with hypersensitivity or idiosyncrasy, such as food allergies. -A person with alcohol or drug dependency. -A person who has participated in other clinical trials within 84 days of giving informed consent. -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. -The person who hopes for pregnancy or the person who can't prevent conception during the clinical study. -Nursing or pregnant woman. -A person whose diagnosis requires treatment of mental illness by a clinical investigator. -A person who are engaged in night duty. -A person who is unable to comply with administrative matters during the clinical study. -A person who are determined ineligible by the clinical investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmation of adverse events
- Secondary Outcome Measures
Name Time Method -Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness -Concomitant medications, adjunctive therapy -Body temperature -Blood pressure/pulse -Height, weight,Body mass index(BMI) -12-lead electrocardiogram -General hematology tests -Blood biochemistry tests -Antioxidants, oxidative stress and adiponectin -Urinalysis -The fecal situation (fecal frequency, fecal volume , fecal property) -Meal recording