Healthy volunteer
Conditions
Interventions
Administration of test food
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals who provided written informed consent to participate in the study. 2) Healthy Japanese adults aged between 20 and 69 years at the time of consent. 3) Postmenopausal women. 4) Individuals who were able to visit the study site and undergo the required examinations on the designated test days.
Exclusion criteria
Exclusion criteria: 1) Individuals deemed unsuitable for participation in the study by the investigator based on clinical laboratory tests or physical examinations. 2) Individuals with a history of serious disorders affecting major organs or systems, or those currently undergoing treatment, who are considered unsuitable for the study by the investigator. 3) Individuals with a current or past history of drug or food allergies. 4) Individuals who regularly take medications, including traditional Japanese (Kampo) medicines. 5) Individuals scheduled to receive any vaccination during the study period. 6) Individuals who donated 200 mL or more of whole blood within 4 weeks prior to the start of test food intake, or 400 mL or more within 12 weeks prior to the start of test food intake. 7) Individuals who tested positive for any of the following: HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology. 8) Any other individuals deemed inappropriate for participation by the investigator or the study director.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood PK parameters | — |
Countries
Japan
Contacts
Public ContactYoshifumi Kotani
Otsuka Pharmaceutical Co., Ltd. Nutraceuticals Research Institute
Outcome results
None listed