UMIN-CTR Clinical Trial

Basic information
Public title	The effect of SNR15 on urinary electrolyte and the pharmacokinetics in healthy volunteers :A randomized, double-blind, placebo-controlled crossover study
Acronym	The effect of SNR15 on urinary electrolyte in healthy volunteers
Scientific Title	The effect of SNR15 on urinary electrolyte and the pharmacokinetics in healthy volunteers :A randomized, double-blind, placebo-controlled crossover study
Scientific Title:Acronym	The effect of SNR15 on urinary electrolyte in healthy volunteers
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of SNR15 on urinary electrolyte
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinary electrolyte
Key secondary outcomes	Plasma concentration of SNR15 metabolite

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Placebo period (9 days) - washout period - SNR15 period (9 days)
Interventions/Control_2	SNR15 period (9 days) - washout period - Placebo period (9 days)
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects who can make self-judgment and are voluntarily giving written informed consent. 2)Healthy males aged between 30 and 64. Healthy post-menopausal females aged between 50 and 64 with no menstruation in the past 12 months. 3)Subjects whose urinary sodium excretion in screening examination is low. 4)Subjects who routinely not take medicine, supplements, FOSHU, and/or health food which affect to the result of the study.
Key exclusion criteria	1)Subjects who have allergy to medicinal and foods. 2)Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease). 3)Subjects whose systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg. 4)Subjects whose BMI is more than 30 kg/m2. 5)Subjects who make a blood donation of 400 ml within 12 weeks before the start of the intake or that of 200 ml within 4 weeks before the start of the intake. 6)Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuma Yonemura
Organization	SOUSEIKAI Sumida Hospital
Division name	Internal medicine
Zip code
Address	1-29-1 Honjo, Sumida-ku, Tokyo
TEL	03-5608-7276
Email	info@tes-h.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ryoma Shimizu
Organization	TES Holdings Co.,Ltd
Division name	Clinical research
Zip code
Address	7-3-1 Hongoh, Bunkyo-ku, Tokyo
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings 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
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 12 Month 18 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	2017 Year 08 Month 22 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 09 Day
Last follow-up date	2017 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 08 Day
Last modified on	2020 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033188