UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043379 |
|---|---|
| Receipt number | R000049530 |
| Scientific Title | To investigate the effect of the test food on blood kinetics of the indicator components A and B. -Randomized, double-blind, two-drug, two-stage crossover study- |
| Date of disclosure of the study information | 2021/02/24 |
| Last modified on | 2021/09/29 17:07:14 |
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Basic information
Public title
To investigate the effect of the test food on blood kinetics of the indicator components A and B.
-Randomized, double-blind, two-drug, two-stage crossover study-
Acronym
To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Scientific Title
To investigate the effect of the test food on blood kinetics of the indicator components A and B.
-Randomized, double-blind, two-drug, two-stage crossover study-
Scientific Title:Acronym
To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the blood concentration-time curve of A.
Key secondary outcomes
Blood concentration of A and B at each time point after ingestion of the test food.
Cmax,Tmax of A.
AUC,Cmax,Tmax of B.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food-Intake of control food.
Interventions/Control_2
Intake of control food-Intake of test food.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Between the ages of 20 and 50 years old.
2.Japanese males and females.
Key exclusion criteria
1.Subjects who have a history of or undergoing treatment for a serious disease.
2.Subjects who have a history of or undergoing treatment for diseases that affect digestion and absorption.
3.Subjects who have a history of gastrointestinal resection surgery, excluding appendicectomy.
4.Subject who can`t discontinue health foods, supplements, or medications that may affect the study during the study period.
5.Subjects who may have allergies related to the test food.
6.Subjects who have a smoking habit.
7.Subjects who have difficulty in taking blood samples.
8. Subjects who are pregnant or plan to become pregnant or breastfeed during this study.
9.Subjects who are judged by principal investigator or the person in charge to be unsuitable as subjects.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Watanabe |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3510
Homepage URL
mizuki1604@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Clinical Research Ethics Committee of FANCL Corporation
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel
045-820-3657
akihide_nisihara@fancl.co.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
| 2021 | Year | 02 | Month | 24 | 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
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049530
