Healthy person
Conditions
Interventions
SAFETY
Sponsors
Medical Fusion Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. 1) Healthy Japanese men and women aged more than 20 years, less than 45 years at the time of giving informed consent. 2) A person of Japanese nationality for 20 years. 3) A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. 4) A person who has freely given consent and has understood the purpose of the study. 5) BMI:18.5 -30.0 6) Blood pressure Systolic blood pressure : less than 159mmHg Diastolic blood pressure : less than 99mmHg 7) Pulse rate 50-100 times/minute 8) Body temperature 35.5-37.0 degrees 9) Excessive exercise can prevent a person from participating in the clinical study. 10) Excessive eating can prevent a person from participating in the clinical study. 11) Women of childbearing ages who consent avoidance of the pregnancy during the clinical study. 12) Participant who understands that clinical visits are mandatory during clinical study period. 13) A person who are considered fit for the enrollment in the clinical study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| -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 | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion Co.,Ltd. Clinical development division
Outcome results
None listed