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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041582
Receipt No. R000047468
Scientific Title Pharmacokinetics of test food in healthy volunteers
Date of disclosure of the study information 2021/10/13
Last modified on 2020/12/03

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Basic information
Public title Pharmacokinetics of test food in healthy volunteers
Acronym Pharmacokinetics of test food in healthy volunteers
Scientific Title Pharmacokinetics of test food in healthy volunteers
Scientific Title:Acronym Pharmacokinetics of test food in healthy volunteers
Region
Japan

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

Objectives
Narrative objectives1 To examine the pharmacokinetics of test food in healthy adult males after single ingestion of test food A (3 doses) and to compare it with test food B.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma metabolites concentration.
Key secondary outcomes Urinary metabolites concentration.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of test food B > washout > Single ingestion of test food A (5mg) > washout > Single ingestion of test food A (20mg) > washout > Single ingestion of test food A (80mg)
Interventions/Control_2
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
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 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 by principal investigator.
2) Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator.
3) Subjects who take medicines for treatment of diseases.
4) Subjects who have food allergy.
5) Subjects who make a blood donation of 200 ml within 4 weeks before the start of the intake or that of 400 ml within 12 weeks before the start of the intake.
6) Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tsuneyuki
Middle name
Last name Noda
Organization Otsuka Pharmaceutical Co., Ltd
Division name Saga Nutraceuticals Research Institute
Zip code 842-0195
Address 5006-5 Yoshinogari, Kanzaki, Saga
TEL 0952-52-1522
Email Noda.tsuneyuki@otsuka.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Manabe
Organization SOUSEIKAI Fukuoka Mirai Hospital
Division name Clinical Research Center, Planning and Coordination Dept.
Zip code 813-0017
Address 3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL 092-662-3608
Homepage URL
Email junko-manabe@lta-med.com

Sponsor
Institute SOUSEIKAI Fukuoka Mirai Hospital
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 Hakata Clinic Institutional Review Board
Address 6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel 092-238-7701
Email miyako-koga@lta-med.com

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
2021 Year 10 Month 13 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
2020 Year 08 Month 24 Day
Date of IRB
2020 Year 08 Month 25 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2020 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 28 Day
Last modified on
2020 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047468

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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