UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063275 |
|---|---|
| Receipt number | R000072426 |
| Scientific Title | Pharmacokinetics study of food ingredient. |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/14 16:39:59 |
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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
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
Food intake
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Japanese 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 and <30 kg/m2
(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 Those with SBP <90 mmHg at screening
2 Those who donated/plan to donate >=200 mL of blood (component or whole blood) within 4 weeks before the study begins
3 Those who donated/plan to donate >=400 mL of whole blood within 12 weeks before the study begins
4 Those whose total blood donation volume during the 12 months before the study, plus planned blood collection in this study, exceeds 1,200 mL
5 Those participating in another study, within 4 weeks after completing another study, or planning to participate in another study during this study
6 Those with heart, liver, or kidney disease (including complications); history of cardiovascular disease; diabetes; allergy to test food, including load food or controlled diet; or history of serious disease such as cancer or tuberculosis
7 Those receiving any medical treatment at screening
8 Those with reduced renal function
9 Those with severe drug or food allergies
10 Those who previously experienced discomfort or deterioration in physical condition due to blood collection
11 Those for whom peripheral venous blood collection is difficult
12 Those whose average daily alcohol consumption exceeds 60 g of pure alcohol
13 Those who smoke or quit smoking less than 3 months ago
14 Those with extremely irregular eating habits
15 Those who work shifts or night shifts
16 Those who regularly use pharmaceuticals, quasi-drugs, Foods for Specified Health Uses, Foods with Function Claims, or health foods
17 Those whose screening results for syphilis, HBs antigen, HCV antibody, or HIV antigen/antibody are not negative
18 Those judged unsuitable as study subjects by the principal investigator or sub-investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kominami |
Organization
Suntory Holdings Limited
Division name
Group Quality Division Safety Science Institute
Zip code
619-0284
Address
8-8-1 Seikadai, Seika-cho, Kyoto
TEL
050-1804-0279
Masaru_Kominami@suntory.co.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kominami |
Organization
Suntory Holdings Limited
Division name
Group Quality Division Safety Science Institute
Zip code
619-0284
Address
8-8-1 Seikadai, Seika-cho, Kyoto
TEL
050-1804-0279
Homepage URL
Masaru_Kominami@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
The Ethics Review Committee of Shin-Sapporo Seiryo Hospital, Medical Corporation Shoreikan
Address
4-2-1-30 Atsubetsu-higashi, 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 | 10 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 11 | 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
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072426
