UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042938 |
|---|---|
| Receipt number | R000048991 |
| Scientific Title | Investigation of ampelopsin absorption by different dosage forms: An open-label, randomized, three-drug, three-period, Latin square design, crossover study |
| Date of disclosure of the study information | 2023/12/05 |
| Last modified on | 2022/02/17 17:41:21 |
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Basic information
Public title
Investigation of ampelopsin absorption by different dosage forms: An open-label, randomized, three-drug, three-period, Latin square design, crossover study
Acronym
Investigation of ampelopsin absorption by different dosage forms
Scientific Title
Investigation of ampelopsin absorption by different dosage forms: An open-label, randomized, three-drug, three-period, Latin square design, crossover study
Scientific Title:Acronym
Investigation of ampelopsin absorption by different dosage forms
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the absorption of ampelopsin by different dosage forms of ampelopsin containing supplements
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under curve of blood ampelopsin
Key secondary outcomes
Blood ampelopsin concentration, blood ampelopsin concentration Cmax and Tmax at each time point after ingestion of the test food
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement 1-Intake of test supplement 3-Intake of test supplement 2
Interventions/Control_2
Intake of test supplement 2-Intake of test supplement 1-Intake of test supplement 3
Interventions/Control_3
Intake of test supplement 3-Intake of test supplement 2-Intake of test supplement 1
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Japanese males between the ages of 20 and 45 years old at the time of informed consent
Key exclusion criteria
1) Subjects with a history of or undergoing treatment for a serious disease
2) Subjects with a history of, or undergoing treatment for, diseases that affect digestion and absorption
3) Subjects with a history of gastrointestinal resection surgery, excluding appendicectomy
4) Subjects who may have allergies related to the test food ( e.g., shrimp and crab allergies)
5) Subjects who regularly consume food containing ampelopsin
6) Subjects who have difficulty in taking blood samples
7) Persons who are judged by principal investigator or the person in charge to be unsuitable as subjects
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Uotsu |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458203755
uotsu_nobuo@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Shimizu |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458203755
Homepage URL
shimizu_yoshiki@fancl.co.jp
Sponsor or person
Institute
FANCL Research Institute, FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Research Institute, FANCL Corporation
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
Clinical Research Ethics Committee of FANCL Corporation
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
045-820-3657
akihide_nisihara@fancl.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 | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048991
