UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043413 |
|---|---|
| Receipt number | R000049566 |
| Scientific Title | A pharmacokinetic study of flavonoids derived from food |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/08/24 09:05:06 |
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Basic information
Public title
A pharmacokinetic study of flavonoids derived from food
Acronym
A pharmacokinetic study of flavonoids derived from food
Scientific Title
A pharmacokinetic study of flavonoids derived from food
Scientific Title:Acronym
A pharmacokinetic study of flavonoids derived from food
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of flavonoids derived from food
Basic objectives2
Others
Basic objectives -Others
To evaluate the absorption of food-derived ingredients from the digestive tract
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time-dependent change of blood flavonoids from administration to 24 hours
Key secondary outcomes
The area under the curve (AUC0-24)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of 5 tablets of food containing flavonoids
Interventions/Control_2
Single ingestion of 5 tablets of placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Males and females whose age are 20<= years old when the consent is obtained.
(2) Subjects who receive an explanation about this trial in advance, understand the content, agree with the purpose, and obtain the written consent.
Key exclusion criteria
(1) Subjects whose systolic blood pressure is under 90 mmHg.
(2) Subjects who fall under any of the following items;
A) Subjects with heart, liver, or kidney disease (including complications of other diseases)
B) Subjects with a history of cardiovascular disease
C) Subjects with diabetes
D) subjects with a history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, intestinal resection, etc.) that may affect drug absorption
E) Subjects with or suspected gastrointestinal obstruction and gastrointestinal motility
F) Subjects with abnormal vomiting reflex
G) Subjects with test food or drug allergies (including allergies to alcohol used to disinfect the puncture site)
H) Subjects who donated 400 mL or more within 90 days, 200 mL or more within 60 days, or those who donated component blood within 30 days
I) Pregnant or potentially pregnant women, and lactating women
(3) Subjects who ingested rose hips, strawberries, linden, grapefruit, foods containing St. Jones wort and dietary supplements (including supplements and beverages) within 3 days before the start of this study.
(4) Subjects who drink habitually (drinking 40 g of pure alcohol or more twice a week) or who drank within 2 days before the start of this study.
(5) Subjects who have a smoking habit and those who smoked within 2 days after the start of this study.
(6) Subjects who show a positive reaction with HBs antigen, HCV antibody, syphilis serum reaction and HIV antigen / antibody.
(7) Subjects with a lean type (BMI less than 18.5).
(8) Subjects who are judged to be unsuitable for the test by the investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hirosato |
| Middle name | |
| Last name | Kawakami |
Organization
Morishita Jintan Co.,Ltd.
Division name
Health Care Product Department
Zip code
573-0128
Address
11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL
072-800-1044
h-kawakami@jintan.co.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Nagatomo |
Organization
Morishita Jintan Co.,Ltd.
Division name
Health Care Product Department
Zip code
573-0128
Address
11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL
072-800-1044
Homepage URL
a-nagatomo@jintan.co.jp
Sponsor or person
Institute
Morishita Jintan Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International Institute for Integrative Sleep Medicine, University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morishita Jintan Institutional Review Board
Address
11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
Tel
06-6761-1131
y-takeda@jintan.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049566
