UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study
Title of the study (Brief title)	Pharmacokinetics study of SNR15
Region	Japan

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

Objectives
Narrative objectives1	To examine the Pharmacokinetics of SNR15
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	placebo (single ingestion) - washout period - SNR15 A (single ingestion) - washout period - SNR15 B (single ingestion)
Interventions/Control_2	SNR15 A (single ingestion) - washout period - SNR15 B (single ingestion) - washout period - placebo (single ingestion)
Interventions/Control_3	SNR15 B (single ingestion) - washout period - placebo (single ingestion) - washout period - SNR15 A (single ingestion)
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 who routinely do 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 who systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg. 4)Subjects who 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 4weeks before the start of the intake. 6)Subjects who are estimated inappropriate to this study by principal investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	Tsuneyuki Noda
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Address	5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzaki-gun, Saga
TEL	0952-52-1522
Email	Noda.Tsuneyuki@otsuka.jp

Public contact
Name of contact person	Tsuneyuki Noda
Organization	Otsuka Pharmaceutical Co.,Ltd.
Division name	Saga Nutraceuticals Research Institute
Address	5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzaki-gun, Saga
TEL	0952-52-1522
Homepage URL
Email	Noda.Tsuneyuki@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)

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	大塚製薬株式会社 佐賀栄養製品研究所（佐賀県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 25 Day
Anticipated trial start date	2016 Year 11 Month 05 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	2016 Year 11 Month 04 Day
Last modified on	2017 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028287