UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039083 |
|---|---|
| Receipt number | R000044573 |
| Scientific Title | Pharmacokinetic analysis of novel curcumin preparation in health volunteer |
| Date of disclosure of the study information | 2020/01/08 |
| Last modified on | 2021/05/27 13:39:50 |
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Basic information
Public title
Pharmacokinetic analysis of novel curcumin preparation in health volunteer
Acronym
Pharmacokinetic analysis of novel curcumin preparation in health volunteer
Scientific Title
Pharmacokinetic analysis of novel curcumin preparation in health volunteer
Scientific Title:Acronym
Pharmacokinetic analysis of novel curcumin preparation in health volunteer
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate pharmacokinetic analysis of novel curcumin preparation in healthy volunteer
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum curcumin concentration
AUC
Cmax
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are 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
Intervention, group A
Novel curcumin preparation 1
90mg/day for 1 day
A washout period for 1 weeks
Novel curcumin preparation 2
90mg/day for 1 day
A washout period for 1 weeks
Theracurmin 90mg/day for 1 day
Interventions/Control_2
Intervention, group B
Novel curcumin preparation 2
90mg/day for 1 day
A washout period for 1 weeks
Theracurmin 90mg/day for 1 day
A washout period for 1 weeks
Novel curcumin preparation 1
90mg/day for 1 day
Interventions/Control_3
Intervention, group C
Theracurmin 90mg/day for 1 day
A washout period for 1 weeks
Novel curcumin preparation 1
90mg/day for 1 day
Novel curcumin preparation 2
A washout period for 1 weeks
90mg/day for 1 day
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 and Female
Key inclusion criteria
The healthy volunteers
Key exclusion criteria
1) The person with underlying disease
2) Pregnancy and nursing
3) Cognitive impairment
4) The person who uses the supplement which influence stiff shoulder
5) The person who participates in other clinical trials at the time of this study entry
6) etc
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Morimoto |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
4228526
Address
52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL
0542645765
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Sunagawa |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
4228526
Address
52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL
0542645765
Homepage URL
y.sunagawa@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
NHO, Kyoto medical centor
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Therabiopharma ltd.
Name of secondary funder(s)
Therabiopharma ltd.
IRB Contact (For public release)
Organization
University of Shizuoka
Address
52-1, Yata, Suruga
Tel
0542645102
rinri@u-shizuoka-ken.ac.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
| 2020 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
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
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044573
