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Assessment of flavonoid Pharmacokinetics following single test food intake in healthy adult men

Assessment of flavonoid Pharmacokinetics following single test food intake in healthy adult men - Assessment of flavonoid Pharmacokinetics following single test food intake in healthy adult men

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052305
Enrollment
18
Registered
2023-09-25
Start date
2023-09-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy individuals

Interventions

Test food 1 (single ingestion) -Washout period-Test food 2 (single ingestion) -Washout period-Test food 3 (single ingestion) Test food 2 (single ingestion) -Washout period-Test food 3 (single ingestio

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

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 (granules, tablet). 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

MeasureTime frame
Flavonoid plasma kinetics parameters

Secondary

MeasureTime 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

toya@huma-rd.co.jp03-3431-1260

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026