UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002917 |
|---|---|
| Receipt number | R000003554 |
| Scientific Title | Chronopharmacokinetic study of arbekacin |
| Date of disclosure of the study information | 2009/12/18 |
| Last modified on | 2009/12/18 11:41:19 |
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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
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
yoshiyamay@pharm.kitasato-u.ac.jp
Sponsor or person
Institute
Division of Community Pharmacy Kitasato University School of Pharmacy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003554
