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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002917
Receipt No. R000003554
Scientific Title Chronopharmacokinetic study of arbekacin
Date of disclosure of the study information 2009/12/18
Last modified on 2009/12/18

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Basic information
Public title Chronopharmacokinetic study of arbekacin
Acronym Chronopharmacokinetic study of arbekacin
Scientific Title Chronopharmacokinetic study of arbekacin
Scientific Title:Acronym Chronopharmacokinetic study of arbekacin
Region
Japan

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

Objectives
Narrative objectives1 Chronopharmacokinetics of arbekacin
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Chronopharmacokinetic parameters
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Morinig administration
Interventions/Control_2 Evening administration
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
45 years-old >=
Gender Male
Key inclusion criteria Age
Key exclusion criteria Allergy
Disease
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Yoshiyama
Organization Kitasato University School of Pharmacy
Division name Division of Community Pharmacy
Zip code
Address 5-9-1, Shirokane- Minato-ku, Tokyo 108-8641 Japan
TEL 03-5791-6341
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Yoshiyama
Organization Kitasato University School of Pharmacy
Division name Division of Community Pharmacy
Zip code
Address 5-9-1, Shirokane- Minato-ku, Tokyo 108-8641 Japan
TEL 03-5791-6341
Homepage URL
Email yoshiyamay@pharm.kitasato-u.ac.jp

Sponsor
Institute Division of Community Pharmacy Kitasato University School of Pharmacy
Institute
Department

Funding Source
Organization Division of Community Pharmacy Kitasato University School of Pharmacy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 北里大学臨床薬理研究所ほうせん診療所(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 18 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 11 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 18 Day
Last modified on
2009 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003554

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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