UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY)
Acronym	Pharmacokinetics study of food ingredient.
Scientific Title	Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY)
Scientific Title:Acronym	Pharmacokinetics study of food ingredient.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the pharmacokinetics of food ingredient.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	t1/2 Cmax Tmax
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of test food
Interventions/Control_2
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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy male and female whose age are 40 <= years old <70. (2)Subjects who are able to submit the written informed consents.
Key exclusion criteria	(1)Subjects who are with treatment. (2)Subjects who are with history of gastrointestinal surgery. (3)Subjects who are attending other studies or attended other studies within the past 4 weeks. (4)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods. (5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody, HIV antigen/antibody or HTLV-1 antibody test. (6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takanori Teramoto
Organization	Suntory Beverage & Food Limited
Division name	Development and Design Department
Zip code
Address	13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL	050-3182-6114
Email	Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person	1st name Middle name Last name Noriyuki Kanzaki
Organization	Suntory Beverage & Food Limited
Division name	Development and Design Department
Zip code
Address	13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL	050-3182-0666
Homepage URL
Email	Noriyuki_Kanzaki@suntory.co.jp

Sponsor
Institute	Suntory Beverage & Food Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
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	2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 11 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038866

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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