UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061419 |
|---|---|
| Receipt number | R000070277 |
| Scientific Title | Pharmacokinetics study of food ingredient |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/11 17:50:17 |
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Basic information
Public title
Pharmacokinetics study of food ingredient
Acronym
Pharmacokinetics study of food ingredient
Scientific Title
Pharmacokinetics study of food ingredient
Scientific Title:Acronym
Pharmacokinetics study of food ingredient
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of food ingredient
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food 1 intake -> washout period -> Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 4 intake
Interventions/Control_2
Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 4 intake -> washout period -> Food 1 intake
Interventions/Control_3
Food 3 intake -> washout period -> Food 4 intake -> washout period -> Food 1 intake -> washout period -> Food 2 intake
Interventions/Control_4
Food 4 intake -> washout period -> Food 1 intake -> washout period -> Food 2 intake -> washout period -> Food 3 intake
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Males who are 20 years of age or older at the time of obtaining consent and under 65 years of age at the end of the intake period
(2) Individuals whose BMI at the screening test is 18.5~30
(3) Individuals who are not receiving any medical treatment at the time of study participation
(4) Individuals who are able to visit the designated facility on the scheduled visit days
(5) Individuals who fully understand the purpose and details of this study and provide written informed consent
Key exclusion criteria
(1) Individuals whose systolic blood pressure at the screening test is below 90 mmHg
(2) Individuals who have donated (or are scheduled to donate) 200 mL or more of blood, either as component donation or whole blood, from 4 weeks before the start of the study until the study begins
(3) Individuals who have donated (or are scheduled to donate) 400 mL or more of whole blood from 12 weeks before the start of the study until the study begins
(4) Individuals whose total blood donation volume from the month 12 months prior to the study start up to the study start, plus the planned total blood collection volume for this study, exceeds 1,200 mL
(5) Individuals who are currently participating in another study as study subjects, who have participated in another study within 4 weeks after its completion, or who plan to participate in another study during the study period
(6) Individuals with a history of serious diseases
(7) Individuals who are receiving any kind of medical treatment at the time of the screening test
(8) Individuals with reduced renal function
(9) Individuals with severe drug or food allergies
(10) Individuals who have previously experienced discomfort or deterioration of physical condition due to blood collection
(11) Individuals for whom venous blood collection from peripheral veins is difficult
(12) Individuals whose average daily alcohol consumption exceeds 60 g of pure alcohol
(13) Individuals who smoke or have quit smoking for less than 3 months
(14) Individuals with extremely irregular eating habits
(15) Individuals who work in shifts or work night shifts
(16) Individuals who are judged by the principal investigator or sub-investigator to be unsuitable as study subjects
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | MASAYUKI |
| Middle name | |
| Last name | IDA |
Organization
Suntory Holdings Limited
Division name
Innovation Planning Department
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo
TEL
050-1804-0336
Masayuki_Ida@suntory.co.jp
Public contact
Name of contact person
| 1st name | MASAYUKI |
| Middle name | |
| Last name | IDA |
Organization
Suntory Holdings Limited
Division name
Innovation Planning Department
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo
TEL
050-1804-0336
Homepage URL
Masayuki_Ida@suntory.co.jp
Sponsor or person
Institute
Suntory Holdings Limited
Institute
Department
Personal name
Funding Source
Organization
None
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
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital Ethics Review Board
Address
1-30, Atsubetsu Higashi 4-jo 2-chome, Atsubetsu-ku, Sapporo, Hokkaido
Tel
011-898-2151
chiken-be@hpgr.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
| 2026 | Year | 05 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070277
