UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022333 |
|---|---|
| Receipt number | R000025739 |
| Scientific Title | The Blood concentration confirmation study on silymarin formulation of process materials. |
| Date of disclosure of the study information | 2016/05/17 |
| Last modified on | 2016/11/16 09:42:19 |
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Basic information
Public title
The Blood concentration confirmation study on silymarin formulation of process materials.
Acronym
The Blood concentration confirmation study on silymarin formulation of process materials.
Scientific Title
The Blood concentration confirmation study on silymarin formulation of process materials.
Scientific Title:Acronym
The Blood concentration confirmation study on silymarin formulation of process materials.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate effects on bioavailability of silymarin
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood silymarin concentration after single ingestion of silymarin formulation
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of silymarin formulation of process materials
Interventions/Control_2
Single ingestion of silymarin formulation of raw materials
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
Key inclusion criteria
1)Healthy males and females aged 20 to 50 years
2)BMI >=18.5 kg/m2 and <30kg/m2
Key exclusion criteria
1)Subjects who previous serious disease.
2)Subjects who are taking medicine or being treated by a doctor
3)Subjects who previous or present serious disease that affect the digestion or being treated by a doctor because of the digestive tract disease
4)Subjects who plan to receive treatment or medication by a doctor during the study
5)Subjects who has chrysanthemum allergy
6)Subjects who use specified healthy food, supplement containing silymarin within the last one month prior to the current study
7)Subjects who cannot be performed over time blood collection
8)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayuri Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Tsubokawa |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
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
Address
Tel
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
| 2016 | Year | 05 | Month | 17 | 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
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 17 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025739
