UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004570 |
|---|---|
| Receipt number | R000005280 |
| Scientific Title | Pharmacokinetic study of sulpiride in humans using [C-11]sulpiride |
| Date of disclosure of the study information | 2010/11/16 |
| Last modified on | 2010/11/16 19:54:31 |
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Basic information
Public title
Pharmacokinetic study of sulpiride in humans using [C-11]sulpiride
Acronym
Pharmacokinetics of [C-11]sulpiride
Scientific Title
Pharmacokinetic study of sulpiride in humans using [C-11]sulpiride
Scientific Title:Acronym
Pharmacokinetics of [C-11]sulpiride
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will observe the pharmacokinetics of [C-11]sulpiride in the whole body using PET-CT. We will also observe whether the pharmacokinetics will change or not after oral administration of a therapeutic dose of sulpiride.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetics of [C-11]sulpiride and its changes after oral administration of sulpiride in a therapeutic dose
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous injection of [C-11]sulpiride for PET-CT imaging in baseline and after oral administration of a therapeutic dose of sulpiride.
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 male subjects who have the ability to provide informed consent
Key exclusion criteria
-Psychiatric disorders including drug dependence
-Serious medical illness
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Molecular Imaging Center, National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University Graduate School
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
独立行政法人 放射線医学総合研究所
National Institute of Radiological Sciences
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 16 | 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
| 2010 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 16 | Day |
Last modified on
| 2010 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005280
