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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039083
Receipt No. 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 2020/05/11

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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
Email 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
Email y.sunagawa@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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
Email 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 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 No longer recruiting
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
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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