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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019907
Receipt No. R000022917
Scientific Title Pharmacokinetics of colchicine in human plasma and leukocytes
Date of disclosure of the study information 2015/11/26
Last modified on 2015/11/24

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Basic information
Public title Pharmacokinetics of colchicine in human plasma and leukocytes
Acronym PK study of colchicine
Scientific Title Pharmacokinetics of colchicine in human plasma and leukocytes
Scientific Title:Acronym PK study of colchicine
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Modeling and simulation of pharmacokinetics of colchicine for the appropriate dosing
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Concentrations of colchicine in plasma and leukocytes after the single and multiple doses
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral colchicine at 0.25mg or 0.5mg per day for 1 days or seven days
Interventions/Control_2
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
40 years-old >=
Gender Male
Key inclusion criteria Healthy males aged 20 to 40 years old
Key exclusion criteria Subjects with any abnormal findings in physical examinations and laboratory tests.
Subjects on any chronicmedication
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Ueda
Organization University of The Ryukyus
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address Uehara 207, Nishihara-cho, OKinawa
TEL 0988951195
Email blessyou@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Ueda
Organization University of The Ryukyus
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address Uehara 207, Nishihara-cho, OKinawa
TEL 0988951195
Homepage URL
Email blessyou@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

Funding Source
Organization Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 11 Month 26 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 Enrolling by invitation
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 03 Day
Last follow-up date
2016 Year 12 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
2015 Year 11 Month 24 Day
Last modified on
2015 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022917

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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