UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics of test food in healthy volunteers
Acronym	Pharmacokinetics of test food in healthy volunteers
Scientific Title	Pharmacokinetics of test food in healthy volunteers
Scientific Title:Acronym	Pharmacokinetics of test food in healthy volunteers
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the pharmacokinetics of test food in healthy adult males after single ingestion of test food A (3 doses) and to compare it with test food B.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma metabolites concentration.
Key secondary outcomes	Urinary metabolites concentration.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
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 B > washout > Single ingestion of test food A (5mg) > washout > Single ingestion of test food A (20mg) > washout > Single ingestion of test food A (80mg)
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	1) Subjects who are voluntarily giving written informed consent. 2) Healthy males aged between 20 and 60. 3) Subjects who can take meals, eat test foods, take blood samples, take urine samples and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria	1) Subjects whose clinical inspection results are outside of the normal range and who are estimated inappropriate to this study by principal investigator. 2) Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator. 3) Subjects who take medicines for treatment of diseases. 4) Subjects who have food allergy. 5) Subjects who make a blood donation of 200 ml within 4 weeks before the start of the intake or that of 400 ml within 12 weeks before the start of the intake. 6) Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Tsuneyuki Middle name Last name Noda
Organization	Otsuka Pharmaceutical Co., Ltd
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Yoshinogari, Kanzaki, Saga
TEL	0952-52-1522
Email	Noda.tsuneyuki@otsuka.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Manabe
Organization	SOUSEIKAI Fukuoka Mirai Hospital
Division name	Clinical Research Center, Planning and Coordination Dept.
Zip code	813-0017
Address	3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL	092-662-3608
Homepage URL
Email	junko-manabe@lta-med.com

Sponsor
Institute	SOUSEIKAI Fukuoka Mirai Hospital
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd
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	Hakata Clinic Institutional Review Board
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel	092-238-7701
Email	miyako-koga@lta-med.com

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 10 Month 13 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	2020 Year 08 Month 24 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 28 Day
Last modified on	2020 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047468