UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059605 |
|---|---|
| Receipt number | R000068054 |
| Scientific Title | Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/31 16:26:47 |
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Basic information
Public title
Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults
Acronym
Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults
Scientific Title
Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults
Scientific Title:Acronym
Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of the constituent compounds contained in the test substance following its administration to healthy adult subjects.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood PK 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
Administration 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who provided written informed consent to participate in the study.
2) Healthy Japanese adults aged between 20 and 69 years at the time of consent.
3) Postmenopausal women.
4) Individuals who were able to visit the study site and undergo the required examinations on the designated test days.
Key exclusion criteria
1) Individuals deemed unsuitable for participation in the study by the investigator based on clinical laboratory tests or physical examinations.
2) Individuals with a history of serious disorders affecting major organs or systems, or those currently undergoing treatment, who are considered unsuitable for the study by the investigator.
3) Individuals with a current or past history of drug or food allergies.
4) Individuals who regularly take medications, including traditional Japanese (Kampo) medicines.
5) Individuals scheduled to receive any vaccination during the study period.
6) Individuals who donated 200 mL or more of whole blood within 4 weeks prior to the start of test food intake, or 400 mL or more within 12 weeks prior to the start of test food intake.
7) Individuals who tested positive for any of the following: HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology.
8) Any other individuals deemed inappropriate for participation by the investigator or the study director.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yodai |
| Middle name | |
| Last name | Kobayashi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Nutraceuticals Research Institute
Zip code
5200106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
077-519-0111
kobayashi.yodai@otsuka.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotani |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Nutraceuticals Research Institute
Zip code
5200106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
077-519-0111
Homepage URL
kotani.yoshifumi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
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
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
092-283-7701
miyako-koga@lta-med.com
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
| 2025 | Year | 11 | Month | 01 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068054
