UMIN-CTR Clinical Trial

Basic information
Public title	Plasma concentration and urinary excretion of SNR14 in healthy male volunteers after single oral administration of foods containing SNR14
Acronym	Absorption study of SNR14
Scientific Title	Plasma concentration and urinary excretion of SNR14 in healthy male volunteers after single oral administration of foods containing SNR14
Scientific Title:Acronym	Absorption study of SNR14
Region	Japan

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

Objectives
Narrative objectives1	To examine the absorption of SNR14 after single oral administration of foods containing SNR14
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma concentration of SNR14 after single oral administration
Key secondary outcomes	Urinary excretion of SNR14 after single oral administration

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single oral administration of SNR14 A
Interventions/Control_2	Single oral administration of SNR14 B
Interventions/Control_3	Single oral administration of SNR14 C
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 eat test foods. 4)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. 2)Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study. 3)Subjects who take medicines for treatment of diseases. 4)Subjects who have allergy. 5)Subjects who are estimated inappropriate to this study by principal investigator or investigators.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Ikeda
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL	0952-52-1522
Email	Ikeda.Yasutaka@otsuka.jp

Public contact
Name of contact person	1st name Minoru Middle name Last name Akiyama
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL	0952-52-1522
Homepage URL
Email	Akiyama.Minoru@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
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	Otsuka Pharmaceutical Co., Ltd.
Address	Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel	03-6717-1499
Email	shimizu_se@otsuka.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	2019 Year 11 Month 01 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	2019 Year 10 Month 09 Day
Date of IRB	2019 Year 10 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 15 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 30 Day
Last modified on	2020 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043798