Healthy person
Conditions
Interventions
dosing period : 12 weeks dose : usual dose ("
EMFCTR-01"
concentration 11mL/33mL) frequency : once a day
dosing period : 12 weeks dose : 3 times dose 33mL ("
concentration 33mL/33mL) frequency : once a day
dosing period : 12 weeks dose : plasebo 33mL ("
concentration 0mL/33mL) frequency : once a day
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 30 years, less than 55 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. -A person whom the tendency of the property of the feces(the score of the property of the feces/days) is less than 2.5 from the next day of the agreement acquisition day to -1 day. -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 prescription drugs or any over-the-counter 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 housemate is participating or a plan to participate in this clinical study. -A person with taking "tenshi no Lara" within the past for 1 year from an agreement acquisition day. -A women who is postmenopausal -A person who are engaged in night duty. -The person doing the hair dyeing, the permanent wave and the frizzled hair correction, etc. which have an influence on a hair and scalp. -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 |
|---|---|
| Adverse events period : from Visit0 to Visit3 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness -Concomitant medications, adjunctive therapy -Blood pressure/pulse -Body temperature -Height, Weight, Body mass index(BMI) -12-lead electrocardiogram -General hematology tests -Blood biochemistry tests -Urinalysis -The fecal situation (fecal frequency, fecal volume , fecal property) -Meal recording -State of facial skin as examined by Robo Skin Analyzer RSA50. -State of hair as examined by Mobile Skin Analyzer AOT-ST. -Blood pressure pulse wave -Hardness of muscle -CT examination | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion Co.,Ltd. Clinical development division
Outcome results
None listed