UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029063 |
|---|---|
| Receipt number | R000033188 |
| Scientific Title | The effect of SNR15 on urinary electrolyte and the pharmacokinetics in healthy volunteers :A randomized, double-blind, placebo-controlled crossover study |
| Date of disclosure of the study information | 2018/12/18 |
| Last modified on | 2020/03/11 14:15:10 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033188
