UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060214 |
|---|---|
| Receipt number | R000068871 |
| Scientific Title | The comparison of the pharmacokinetics between various formulations containing Brazilian green propolis in healthy volunteers. |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2025/12/26 16:11:29 |
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Basic information
Public title
The comparison of the pharmacokinetics between various formulations containing Brazilian green propolis in healthy volunteers.
Acronym
The comparison of the pharmacokinetics between various formulations containing Brazilian green propolis in healthy volunteers.
Scientific Title
The comparison of the pharmacokinetics between various formulations containing Brazilian green propolis in healthy volunteers.
Scientific Title:Acronym
The comparison of the pharmacokinetics between various formulations containing Brazilian green propolis in healthy volunteers.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the pharmacokinetics of various formulations containing Brazilian green propolis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration and the area under the plasma concentration -time curve of Artepillin C
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Blood samples are collected up to 8 hour after ingestion of each of four formulations. The experimental periods are separated by at least 72 hours as a washout period.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged between 20 and 50 at the time of informed consent.
2. BMI:18.5 - 25.0
Key exclusion criteria
1. Participants who have history of food allergies.
2. Participants who have history of asthma.
3. Participants in pregnancy or in nursing.
4. Participants who are enrolled in another clinical trial during this study.
5. Participants who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, gastrointestinal suturing, intestinal resection and so on.
6. Participants with a current or history of serious illness, such as diabetes, liver disease, kidney diseases, heart diseases, and more.
7. Participants who have taken medication treatment.
8. Participants who can not refrain from consuming for specified foods from dinner on the night before the test until the end of the test.
9. Participants who can not quit smoking from dinner on the night before the test until the end of the test.
10. Participants who are unable to consume the test food as instructed or remain at rest until the completion of the study.
11. Participants who can not prohibit intake of foods, medicines, and supplements containing propolis or flavonoid at least one week prior to the start of this study.
12. Participants who can not continue regular life.
13. Participants who are night workers of shift workers.
14. Participants who have taken the blood sampling either 200 mL within 4 weeks or 400 mL within 3 months.
15. Participants who are heavy drinker ( >500 mL beer per day ) .
16. Participants who are smoking more than 20 cigarettes per day.
17. Participants who are judged as unsuitable for the current in this study by the study director.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamaga |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee product & Health Science, R&D department.
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan.
TEL
0868-54-3825
my1636@yamada-bee.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Haruna |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee product & Health Science, R&D department.
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan.
TEL
0868-54-3825
Homepage URL
yh2064@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Pharmaceutical university.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan.
Tel
0868-54-1199
irb@yamada-bee.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
| 2026 | Year | 01 | Month | 06 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 26 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068871
