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
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
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
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
