UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bioequivalence study of food
Title of the study (Brief title)	Bioequivalence study of food
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the bioequivalence of foods.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
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	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 3-> Washout (5 days or more) -> Single ingestion of test food 4.
Interventions/Control_2	Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3.
Interventions/Control_3	Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 2.
Interventions/Control_4	Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1.
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	49 years-old >=
Gender	Male
Key inclusion criteria	(1)Males whose age are 20 <= years old <= 49. (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 or HIV antigen/antibody test. (6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	R&D Support Department HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Hidenori Obata
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	R&D Support Department HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Homepage URL
Email	Hidenori_Obata@suntory.co.jp

Sponsor
Institute	SUNTORY MONOZUKURI 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 11 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 11 Month 06 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 10 Month 31 Day
Last modified on	2018 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034009