UMIN-CTR Clinical Trial

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