Healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese adult males and females 2. Age of 20 years or older and 70 years or younger 3. Subject with the ability to express his or her consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his or her consent to participate in the present clinical study.
Exclusion criteria
Exclusion criteria: 1. Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function. 2. Subject who has or had hypersensitivity or idiosyncracy (allergy) to sake lees, drug or food. 3. Subject who is unable to maintain the life style stable during the study period. 4. Female who is either pregnant, feeding a baby or wants to have a baby during the study period. 5. Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of test food in this study. 6. Subject who plans to take other drugs (including herbs) or supplements before the end of the present study. 7.Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of biochemical, hematological and urine tests between the time of screening and 4 weeks after the intake of the test food | — |
Countries
Japan
Contacts
Tsukuba International Clinical Pharmacology Clinic Division for Volunteer Control