UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pharmacokinetics study of food ingredient.
Title of the study (Brief title)	A 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	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cmax AUC(0-24h)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Single ingestion of test food 1. Washout(5days or more). Single ingestion of test food 2.
Interventions/Control_2	Single ingestion of test food 2. Washout(5days or more). Single ingestion of test food 1.
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	Not applicable
Gender	Male
Key inclusion criteria	1)Adult males. 2) a)25kg/m2<=BMI<30kg/m2 b)BMI<25kg/m2,120mg/dL<=LDL cholesterol level<=159mg/dL 3)Understanding the study and submitting the written informed consent before the study.
Key exclusion criteria	1)Subjects with treatment. 2)Subjects 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, or, b)With history of cardiac disorder, or, c)With diabetes mellitus, or, d)With allergy to the study foods. 5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test. 6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	44

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Kaori Matsuoka
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Homepage URL
Email	Kaori_Matsuoka@suntory.co.jp

Sponsor
Institute	Suntory Business Expert Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 06 Day
Last modified on	2017 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029906