UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052304 |
|---|---|
| Receipt number | R000059701 |
| Scientific Title | Assessment of flavonoid Pharmacokinetics following single capsule intake in healthy adult men |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2024/07/31 15:30:33 |
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Basic information
Public title
Assessment of flavonoid Pharmacokinetics following single capsule intake in healthy adult men
Acronym
Assessment of flavonoid Pharmacokinetics following single capsule intake in healthy adult men
Scientific Title
Assessment of flavonoid Pharmacokinetics following single capsule intake in healthy adult men
Scientific Title:Acronym
Assessment of flavonoid Pharmacokinetics following single capsule intake in healthy adult men
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obtaining fundamental information on flavonoid pharmacokinetics after single capsule intake in healthy adult men
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flavonoid plasma kinetics parameters
Key secondary outcomes
(Secondary outcomes)
Urinary flavonoid excretion rate
(Safety evaluation)
Frequency of adverse events during the period from intake of the test food to the following day, general physical findings (subjective symptoms, objective findings), vital signs (body weight, body temperature, blood pressure, pulse rate), blood test items, urinalysis items
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food 1 (single ingestion) -Washout period-Test food 2 (single ingestion)
Interventions/Control_2
Test food 2 (single ingestion) -Washout period-Test food 1 (single ingestion)
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Individuals who voluntarily giving written informed consent.
2)Healthy adult males aged between 20 and 60.
3)Individuals able to intake the test food (capsule).
4)Individuals who can intake test foods, etc., take blood samples, take urine samples, and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria
1)Individuals whose clinical inspection results are outside of the normal range and who are estimated inappropriate to this study by principal investigator.
2)Individuals with current or previous disorders of the gastrointestinal, cardiovascular, and endocrine systems who are determined to be ineligible for the study by the investigator.
3)Individuals with smoking habits.
4)As a general rule, individuals who regularly use medicines for treatnemnt of diseases.
5)Individuals with food allergy.
6)Individuals who are currently participating in another study or plan to participate during the study period
7)Individuals who are estimated inappropriate to participate to this study by principal investigator.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, Japan
TEL
077-521-8835
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.co.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 | 09 | Month | 25 | 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
18
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
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059701
