UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050063 |
|---|---|
| Receipt number | R000056929 |
| Scientific Title | Pharmacokinetic study by single intake of the test food (pilot study) |
| Date of disclosure of the study information | 2023/01/21 |
| Last modified on | 2023/04/13 09:53:01 |
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Basic information
Public title
Pharmacokinetic study by single intake of the test food (pilot study)
Acronym
Pharmacokinetic study by single intake of the test food (pilot study)
Scientific Title
Pharmacokinetic study by single intake of the test food (pilot study)
Scientific Title:Acronym
Pharmacokinetic study by single intake of the test food (pilot study)
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 pharmacokinetics of active ingredients during a single intake of the test food
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to maximum concentration (Tmax) of active ingredients
Key secondary outcomes
Blood concentration of active ingredients at each time point after ingestion of the test food
Area Under the Curve(AUC) and Maximum serum concentration(Cmax) of active ingredients
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1) Age: 20-34, healthy male
2) BMI: 18.5 kg/m2-24.9 kg/m2
3) Subjects who giving informed consent.
Key exclusion criteria
1) Subjects with a serious medical history, or with a history of disorders of the digestive system, circulatory system (e.g., heart failure), endocrine system, etc. Subjects who have been judged to be inappropriate for the study by the principal investigator.
2) Subjects who have a history of gastrointestinal resection surgery, excluding appendectomy.
3) Subjects who are currently taking medication or being treated by a physician.
4) Subjects who must be scheduled to receive medical treatment or medication during the study period.
5) Subjects who plan to consume health foods or supplements other than the food under study after consent.
6) Subjects who are unable to consume the test food due to preference or allergy. Subjects who may have allergies related to the test food.
7) Heavy drinkers of alcohol and heavy smokers.
8) Subjects who have difficulty in taking blood samples.
9) Subjects who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks.
10) Subjects who currently or will be participating in another clinical research study during the study period.
11) Subjects who have irregular sleep or eating habits due to night work or insomnia.
12) Subjects who are engaged in strenuous physical activity.
13) Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Naito |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
104-0061
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel
03-3573-1153
isamu-yanase@kenkoin.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
| 2023 | Year | 01 | Month | 21 | 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
| 2022 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056929
