Pharmacokinetic study of food ingredient
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000049201
- Lead Sponsor
- M&I Science CORP.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood concentration of food ingredient
- Secondary Outcome Measures
Name Time Method (Safety evaluation) Adverse events