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Pharmacokinetic study of food ingredient

Pharmacokinetic study of food ingredient - Pharmacokinetic study of food ingredient

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049201
Enrollment
5
Registered
2022-10-17
Start date
2022-10-18
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 subjects

Interventions

Single intake of test food A Single intake of test food B Single intake of test food C

Sponsors

M&I Science CORP.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese male and female subjects between 20 and 60 years of age at the time of consent. 2. Subjects who can have multiple blood draws. 3. Subjects who lead a regular life (subject who eat three meals a day at almost regular intervals). 4. Healthy subjects. 5. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.

Exclusion criteria

Exclusion criteria: 1. Subjects who are currently receiving medication or outpatient treatment for some serious disease. 2. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician. 3. Subjects who may develop allergies to the test food. 4. Subjects who have a current or history of drug dependence or alcohol dependence. 5. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past. 6. Subjects who have irregular rhythm of life due to night work or shift work. 7. Subjects who are with extremely irregular eating, sleeping, or other habits. 8. Subjects who have an extremely unbalanced diet. 9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases. 10. Subjects who use of health foods, supplements, and medications within one month retroactive to the date consent was obtained. 11. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period 12. Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 13. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period. 14. Subjects who have difficulty in complying with the recording of various questionnaires. 15. Other subjects who are judged unsuitable as subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Blood concentration of food ingredient

Secondary

MeasureTime frame
(Safety evaluation) Adverse events

Countries

Japan

Contacts

Public ContactMasao Matsuoka

M&I Science CORP. Clinical Development Department

m.matsuoka@mis21.co.jp06-7878-6780

Outcome results

None listed

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