Healthy volunteer
Conditions
Sponsors
Rohto Pharmaceutical Co.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females between 20 and 65 years of age at the time of consent to participate in the study 2) Subjects with ALT >= 20 U/L and <= 50 U/L in screening test 3) Subjects who can visit on schedule days 4) Subjects who recognize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with chronic diseases and taking medication 2) Subjects with a history of serious liver disease (viral hepatitis, drug-induced liver injury, cirrhosis) or suspected of currently having such disease 3) Subjects suffering from mental illness, sleep disorders, cardiac or renal disease, diabetes or other serious illnesses 4) Subjects with a history of severe illness in the past that would be considered problematic for study participation 5) Subjects who may show allergic symptoms to ingredients in the test food 6) Shift workers or late-night workers whose work schedule exceeds 0:00 AM 7) Subjects with extremely irregular daily habits and eating habits 8) Subjects with systolic blood pressure less than 90 mmHg 9) Subjects with an average daily drinking habit of 60 g/day or more of pure alcohol in the one-week alcohol consumption survey starting the day after the screening test 10) Subjects who have experienced moodiness or worsening of physical condition due to blood collection in the past 11) Subjects who regularly use medicines, quasi-drugs, herbal medicines, or health foods (including supplements) that may affect the study 12) Subjects who fail to comply with the requests to subjects during the study period 13) Subjects participating in another clinical trial at the time of screening test or within 2 months prior to study entry 14) Subjects who have donated component blood or had at least 200 mL of whole blood drawn in the month prior to the screening test or plan to do so during the study period 15) Subjects who have an average of 10 or more days per month of business travel or trips 16) Subjects who wish to become pregnant, are pregnant (including possible pregnancy), or are lactating 17) Other subjects deemed inappropriate by the investigator based on medical examination data, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes AST, gamma-GT, Fatigue VAS, OSA-MA, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, glucose, HbA1c(NGSP) Safety outcomes Incidence of side effects, Adverse Event Rate Other outcomes Physical measurement items, Physiological test items, Laboratory test items excluding efficacy endpoints | — |
Countries
Japan
Contacts
Public ContactKanako Zembutsu
New drug research center, Inc. Clinical Research Group of Food Clinical Research Dept.
Outcome results
None listed