UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024719
Receipt number R000028287
Scientific Title Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study
Date of disclosure of the study information 2017/12/18
Last modified on 2017/12/18 08:33:31

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Basic information

Public title

Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study

Acronym

Pharmacokinetics study of SNR15

Scientific Title

Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study

Scientific Title:Acronym

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

1st name
Middle name
Last name Tsuneyuki Noda

Organization

Otsuka Pharmaceutical Co., Ltd.

Division name

Saga Nutraceuticals Research Institute

Zip code


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

1st name
Middle name
Last name Tsuneyuki Noda

Organization

Otsuka Pharmaceutical Co.,Ltd.

Division name

Saga Nutraceuticals Research Institute

Zip code


Address

5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzaki-gun, Saga

TEL

0952-52-1522

Homepage URL


Email

Noda.Tsuneyuki@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



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

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


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

2016 Year 10 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name