Healthy adults
Conditions
Interventions
Intake normal dose of test food for 84 days, every day
Sponsors
Kowa Company, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subject must satisfy the following selection criteria. 1) Healthy Japanese aged from 20 to 45 years-old at the time of giving informed consent 2) A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy 3) A person who has freely given informed consent and has fully understood the purpose of the study 4) A person whose BMI is from 18.5 to 30.0 5) When measuring blood pressure twice, a person whose average blood pressure is within a range of followings;Systolic blood pressure: less than or equal to 139mmHg Diastolic blood pressure: less than or equal to 89mmHg 6) A person whose pulse rate is from 40 to 100 per minute 7) A person whose body temperature is from 35.5 to 37.0 degree Celsius 8) A person who can prevent from excessive exercise during the study 9) A person who can basically have 3 meals in a day during the study 10) A person who can conduct contraception by appropriate ways during the study 11) A person who understands and follows rules and requirements during the study 12) A person who is considered totally fit for participating the study by a comprehensive judgement of lead principal investigator and others.
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to subjects. 1) A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food 2) A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the a ppendectomy are excluded) 3) A person with a history of cerebrovasculardisorder (the asymptomatic lacunar infarct is excluded) 4) A person with tattoo which has an influence on the study because of its size or range 5) A person with hypersensitivity or idiosyncrasy, such as food allergy 6) A person who is suspected to have alcohol or drug dependence 7) A person who has participated in other clinical trials within 84 days from giving an informed consent 8) A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent 9) A person who hopes pregnancy or who cannot prevent conception during the study 10) A nursing or pregnant woman 11) A person who is engaged in night duty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Appearance of adverse events -Height, weight and BMI -Body temperature, blood pressure and pulse -12-lead electrocardiogram -General hematology test -Blood biochemistry test -Urinalysis | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medeical Fusion Co.,Ltd. Clinical development division
Outcome results
None listed