UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057947 |
|---|---|
| Receipt number | R000066247 |
| Scientific Title | Investigation of the pharmacokinetics following oral administration of the test food |
| Date of disclosure of the study information | 2025/05/24 |
| Last modified on | 2025/11/25 15:46:47 |
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Basic information
Public title
Investigation of the pharmacokinetics following oral administration of the test food
Acronym
Investigation of the pharmacokinetics following oral administration of the test food
Scientific Title
Investigation of the pharmacokinetics following oral administration of the test food
Scientific Title:Acronym
Investigation of the pharmacokinetics following oral administration of the test food
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetics of the test food following oral administration
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative analysis of low-molecular-weight compounds transferred into the bloodstream following the intervention
Key secondary outcomes
Quantitative analysis of low-molecular-weight compounds transferred into the bloodstream following the intervention
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Single intake of the 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are t taking medications that affect the gastrointestinal system (including Kampo medicines) and/or supplements containing peptides or amino acids
5. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to eggs
6. Individuals whose BMI is less than 18.5 kg/m2 or 30 kg/m2 or more
7. Individuals who are undergoing exercise or alimentary therapy under medical supervision
8. Individuals who have a present condition or have a medical history of drug or alcohol dependence
9. Individuals who are undergoing treatment for psychiatric disorder (including depressive symptoms) or sleep disorder
10. Individuals who are pregnant, lactating, or planning to become pregnant during this study
11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
12. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryohara, Nishikyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-748-9829
y-yamashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Tamura |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryohara, Nishikyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-748-9829
Homepage URL
aoi-tamura@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Taifukukai Osaka Nishi-Umeda Clinic Clinical Research Ethics Review Board
Address
Hotel Monterey Osaka (Maruito Nishi-Umeda Building) office floor 3F 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
n-irb@ml.taifukukai.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
医療法人大福会 大阪西梅田クリニック (大阪府)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066247
