UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041582 |
|---|---|
| Receipt number | 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 10:26:05 |
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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
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
junko-manabe@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Fukuoka Mirai Hospital
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
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
092-238-7701
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047468
