UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050522 |
|---|---|
| Receipt number | R000057476 |
| Scientific Title | Study on the absorption of indicator components after ingestion of a new sustained-release formulation -A randomized, single blind, 2-way, 2-period, cross-over study- |
| Date of disclosure of the study information | 2023/03/08 |
| Last modified on | 2023/09/05 09:23:49 |
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Basic information
Public title
Study on the absorption of indicator components after ingestion of a new sustained-release formulation
Acronym
Study on the absorption of indicator components after ingestion of a new sustained-release formulation
Scientific Title
Study on the absorption of indicator components after ingestion of a new sustained-release formulation -A randomized, single blind, 2-way, 2-period, cross-over study-
Scientific Title:Acronym
Study on the absorption of indicator components after ingestion of a new sustained-release formulation
Region
| Japan |
Condition
Condition
Adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the absorption of indicator components of a new sustained release formulation using urinary excretion.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Total urinary excretion of indicator components per 24 hours after ingestion
Key secondary outcomes
Urinary indicator components excretion at each time point after ingestion. Tmax of urinary indicator components, Cmax of urinary indicator components.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of control - washout period - intake of test food (single ingestion).
Interventions/Control_2
Intake of test food - washout period - intake of control (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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Males 20 to 49 years of age.
2) Subjects whose BMI are more than 18.5 kg/m2 less than 25.0 kg/m2.
Key exclusion criteria
1) Subjects with a serious medical history or gastrointestinal surgery.
2) Subjects with diseases affecting gastric excretion and digestion/absorption, or with daily symptoms of indigestion, constipation, diarrhea, etc.
3) Subjects have abnormal renal, hepatic, glucose and lipid metabolic functions.
4) Subjects are taking indicator components-rich drugs or supplements.
5) Subjects are heavy alcohol drinkers or excessive smokers.
6) Subjects who are judged to be unsuitable as subjects by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tarumizu |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
Homepage URL
chie_0904@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
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
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
株式会社ファンケル 総合研究所（神奈川県）/ FANCL Corporation Research Institute(Kanagawa prefecture)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 08 | 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
| 2023 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057476
