Healthy volunteer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals whose written informed consent has been obtained [4]Individuals who can come to the designated examination date and receive the examination [5]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3] Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [5]Individuals with history of gastrointestinal disorders except for appendicitis [6]Individuals with skin disease, such as atopic dermatitis [7]Individuals who have an inflammation or a scar on a measuring area [8]Individuals who will get sunburned during the test period [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [10]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [11]Individuals with serious anemia [12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [14]Individuals whose number of smokers exceeds 20 on average per day [15]Individuals whose life style will change during the test period (ex. travel for a long time) [16]Individuals who are pregnant or are posslibly, or are lactating [17]Individuals who participated in other clinical studies in the past three months [18]Individual with potential conflict of interest [19]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of occurrences of side effects, expression rate (number of side effect examples / number of subjects to be analyzed for safety) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of occurrences of adverse events, incidence (number of adverse event developments / number of subjects to be analyzed for safety) | — |
Countries
Japan
Contacts
DRC Co.,Ltd. Product Testing & Studies Division