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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002327
Receipt No. R000002847
Scientific Title Evaluation of Pharmacokinetic interaction between vitamin K1 and ezetimibe
Date of disclosure of the study information 2009/08/12
Last modified on 2011/02/15

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Basic information
Public title Evaluation of Pharmacokinetic interaction between vitamin K1 and ezetimibe
Acronym Evaluation of Pharmacokinetic interaction between vitamin K1 and ezetimibe
Scientific Title Evaluation of Pharmacokinetic interaction between vitamin K1 and ezetimibe
Scientific Title:Acronym Evaluation of Pharmacokinetic interaction between vitamin K1 and ezetimibe
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate pharmacokinetic interaction between ezetimibe and vitamin K1
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma vitamin K1 concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take Vitamin K1
Interventions/Control_2 Take vitamin K1 and ezetimibe
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer
Key exclusion criteria Taking lipid-lowering drug
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama Higashiku Hamamatsu
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama Higashiku Hamamatsu
TEL
Homepage URL
Email

Sponsor
Institute Department of Hospital Pharmacy, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacology, Hamamatsu University School of Medicine
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
2009 Year 08 Month 12 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
2009 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 12 Day
Last modified on
2011 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002847

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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