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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name