Healthy individuals
Conditions
Interventions
Test food 1 (single ingestion) -Washout period-Test food 2 (single ingestion)
Test food 2 (single ingestion) -Washout period-Test food 1 (single ingestion)
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Individuals who voluntarily giving written informed consent. 2)Healthy adult males aged between 20 and 60. 3)Individuals able to intake the test food (capsule). 4)Individuals who can intake test foods, etc., take blood samples, take urine samples, and stay quiet and rest on the schedule indicated by investigators.
Exclusion criteria
Exclusion criteria: 1)Individuals whose clinical inspection results are outside of the normal range and who are estimated inappropriate to this study by principal investigator. 2)Individuals with current or previous disorders of the gastrointestinal, cardiovascular, and endocrine systems who are determined to be ineligible for the study by the investigator. 3)Individuals with smoking habits. 4)As a general rule, individuals who regularly use medicines for treatnemnt of diseases. 5)Individuals with food allergy. 6)Individuals who are currently participating in another study or plan to participate during the study period 7)Individuals who are estimated inappropriate to participate to this study by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flavonoid plasma kinetics parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Urinary flavonoid excretion rate (Safety evaluation) Frequency of adverse events during the period from intake of the test food to the following day, general physical findings (subjective symptoms, objective findings), vital signs (body weight, body temperature, blood pressure, pulse rate), blood test items, urinalysis items | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed