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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004786
Receipt No. R000005697
Scientific Title PET microdose study of donepezi in humans
Date of disclosure of the study information 2010/12/24
Last modified on 2010/12/24

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Basic information
Public title PET microdose study of donepezi in humans
Acronym Donepezil PET
Scientific Title PET microdose study of donepezi in humans
Scientific Title:Acronym Donepezil PET
Region
Japan

Condition
Condition normal volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to elucidate pharmacokinetics of donepezil in normal volunteers
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes radioactivity of donpezil in the brain
Key secondary outcomes sequential changes in donepezil radioactivity in the brain by 60minafter administration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To analyze pharmacokinetics of C-11 donepezil after 1mg (n=6) oral administration. The study period is from January to March 2022.
Interventions/Control_2 To analyze pharmacokinetics of C-11 donepezil after 3mg (n=6) oral administration. The study period is from January to March 2022.
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria normal volunteer
Key exclusion criteria liver dysfunction, ECG abnormality, past history of gastric ulcer, symptoms of extrapyramidal systems, intake of other drugs, pregnant,
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Hospital
Division name Nuclear Medicine
Zip code
Address 2-2 Yamadaoka Suita, Osaka
TEL 81-6-6879-3461
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Hospital
Division name Nuclear Medicine
Zip code
Address 2-2 Yamadaoka Suita, Osaka
TEL 81-6-6879-3461
Homepage URL http://www.tracer.med.osaka-u.ac.jp/index-jp.htm
Email hatazawa@tracer.med.osaka-u.ac.jp

Sponsor
Institute Department of Nuclear Medicine, Osaka University Hospital
Institute
Department

Funding Source
Organization New Energy and Industrial Technology Development Organization Japan
Organization
Division
Category of Funding Organization
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 24 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 12 Month 24 Day
Last modified on
2010 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005697

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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