Unique ID issued by UMIN | UMIN000051122 |
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Receipt number | R000058274 |
Scientific Title | Pharmacokinetic test by single ingestion of the test food |
Date of disclosure of the study information | 2023/05/22 |
Last modified on | 2023/12/14 16:24:46 |
Pharmacokinetic test by single ingestion of the test food
Pharmacokinetic test by single ingestion of the test food
Pharmacokinetic test by single ingestion of the test food
Pharmacokinetic test by single ingestion of the test food
Japan |
No
Not applicable | Adult |
Others
NO
The study aims to confirm the pharmacokinetics by single ingestion of the test food.
Pharmacokinetics
Blood kinetics
(Blood hesperetin concentration, AUC(0-7h),iAUC(0-7h), Cmax, Tmax)
*Secondary indexes
[1] Blood kinetics
(AUC(0-inf),T1/2,MRT,Kel)
*Safety
[1] Doctor's questions.
[2] Adverse events
*Other indexes
[1] Baseline characteristics
[2] height measurement
[3] Blood pressure, pulsation.
[4] Weight, body fat percentage, BMI
[5] Infectious disease-related tests
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Oral intake of the test product (single ingestion: 2 capsules).
20 | years-old | <= |
60 | years-old | > |
Male and Female
1) Japanese males and females aged 20-59 years.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals whose written informed consent has been obtained.
4) Individuals who can come to the designated venue for this study and be inspected.
5) Individuals judged appropriate for the study by the principal.
1) Individuals using medical products.
2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
4) Individuals who are a patient or have a history of or endocrine disease.
5) Individuals with serious anemia.
6) Individuals who used a drug to treat a disease in the past 1 month.
7) Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2.
8) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
9) Individuals who have and had a habit in the past 1 month to ingest food with functional claims, health foods, or supplements.
10) Individuals who experienced unpleasant feeling during blood drawing.
11) Individuals with drug and food allergies.
12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
13) Individuals who are or are possibly pregnant, or are lactating.
14) Individuals who participated in other clinical studies in the past 1 month.
15) Individuals judged inappropriate for the study by the principal.
10
1st name | Atsushi |
Middle name | |
Last name | Nakajima |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinic
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings Co., Ltd.
DHC Corporation
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
jimukyoku@tes-h.co.jp
NO
2023 | Year | 05 | Month | 22 | Day |
Unpublished
Completed
2023 | Year | 05 | Month | 17 | Day |
2023 | Year | 05 | Month | 18 | Day |
2023 | Year | 05 | Month | 23 | Day |
2023 | Year | 05 | Month | 23 | Day |
2023 | Year | 05 | Month | 22 | Day |
2023 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058274
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