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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038441
Receipt No. R000043798
Scientific Title Plasma concentration and urinary excretion of SNR14 in healthy male volunteers after single oral administration of foods containing SNR14
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/30

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Basic information
Public title Plasma concentration and urinary excretion of SNR14 in healthy male volunteers after single oral administration of foods containing SNR14
Acronym Absorption study of SNR14
Scientific Title Plasma concentration and urinary excretion of SNR14 in healthy male volunteers after single oral administration of foods containing SNR14
Scientific Title:Acronym Absorption study of SNR14
Region
Japan

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

Objectives
Narrative objectives1 To examine the absorption of SNR14 after single oral administration of foods containing SNR14
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentration of SNR14 after single oral administration
Key secondary outcomes Urinary excretion of SNR14 after single oral administration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Single oral administration of SNR14 A
Interventions/Control_2 Single oral administration of SNR14 B
Interventions/Control_3 Single oral administration of SNR14 C
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria 1)Subjects who are voluntarily giving written informed consent.
2)Healthy males aged between 20 and 60.
3)Subjects who can eat test foods.
4)Subjects who can take meals, eat test foods, take blood samples, take urine samples and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria 1)Subjects whose clinical inspection results are outside of the normal range and who are estimated inappropriate to this study.
2)Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study.
3)Subjects who take medicines for treatment of diseases.
4)Subjects who have allergy.
5)Subjects who are estimated inappropriate to this study by principal investigator or investigators.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Yasutaka
Middle name
Last name Ikeda
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code 842-0195
Address 5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL 0952-52-1522
Email Ikeda.Yasutaka@otsuka.jp

Public contact
Name of contact person
1st name Minoru
Middle name
Last name Akiyama
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code 842-0195
Address 5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL 0952-52-1522
Homepage URL
Email Akiyama.Minoru@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)

IRB Contact (For public release)
Organization Otsuka Pharmaceutical Co., Ltd.
Address Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel 03-6717-1499
Email shimizu_se@otsuka.jp

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
2019 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 15 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 30 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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