Healthy person
Conditions
Interventions
daily take 5 times dose
Sponsors
Medical Fusion Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. -Healthy Japanese men and women aged more than 20 years, less than 45 years at the time of giving informed consent. -A person of Japanese nationality for 20 years. -A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. -A person who has freely given consent and has understood the purpose of the study. -BMI:18.5 - 30.0 -Blood pressure Systolic blood pressure:less than 159mmHg Diastolic blood pressure:less than 99mmHg -Pulse rate: 50-100 times/minute -Body temperature: 35.5-37.0 degrees -Excessive exercise can prevent a person from participating in the clinical study. -A person who can take three meals a day basically and prohibit great intemperance during the clinical study. -A person who can conduct contraception by an appropriate way during the clinical study. -Participant who understands that clinical visits are mandatory during clinical study period. -A person who are considered fit for the enrollment in the clinical study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| -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 | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion Co.,Ltd. Clinical development division
Outcome results
None listed