UMIN-CTR Clinical Trial

Basic information
Public title	To investigate the effect of the test food on blood kinetics of the indicator components A and B. -Randomized, double-blind, two-drug, two-stage crossover study-
Acronym	To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Scientific Title	To investigate the effect of the test food on blood kinetics of the indicator components A and B. -Randomized, double-blind, two-drug, two-stage crossover study-
Scientific Title:Acronym	To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the blood concentration-time curve of A.
Key secondary outcomes	Blood concentration of A and B at each time point after ingestion of the test food. Cmax,Tmax of A. AUC,Cmax,Tmax of B.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food-Intake of control food.
Interventions/Control_2	Intake of control food-Intake of test food.
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1.Between the ages of 20 and 50 years old. 2.Japanese males and females.
Key exclusion criteria	1.Subjects who have a history of or undergoing treatment for a serious disease. 2.Subjects who have a history of or undergoing treatment for diseases that affect digestion and absorption. 3.Subjects who have a history of gastrointestinal resection surgery, excluding appendicectomy. 4.Subject who can`t discontinue health foods, supplements, or medications that may affect the study during the study period. 5.Subjects who may have allergies related to the test food. 6.Subjects who have a smoking habit. 7.Subjects who have difficulty in taking blood samples. 8. Subjects who are pregnant or plan to become pregnant or breastfeed during this study. 9.Subjects who are judged by principal investigator or the person in charge to be unsuitable as subjects.
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Mizuki Middle name Last name Watanabe
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3510
Homepage URL
Email	mizuki1604@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Ethics Committee of FANCL Corporation
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel	045-820-3657
Email	akihide_nisihara@fancl.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 02 Month 24 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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 18 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 24 Day
Last follow-up date	2021 Year 03 Month 26 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 19 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049530

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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