UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007391 |
|---|---|
| Receipt number | R000008706 |
| Scientific Title | Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese. |
| Date of disclosure of the study information | 2012/02/28 |
| Last modified on | 2013/02/28 08:41:37 |
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Basic information
Public title
Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese.
Acronym
Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese.
Scientific Title
Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese.
Scientific Title:Acronym
Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese.
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the pharmacokinetics of mirtazapine and effects on plasma levels of bioactive peptides.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma level of mirtazapine, ACTH, NPY. cortisol
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) placebo
2) mirtazapine
Interventions/Control_2
1) mirtazapine
2) placebo
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 and Female
Key inclusion criteria
written informed consent before the study
volunteers ascertained to be healthy by a medical history, a physical examination
Key exclusion criteria
smokers
pregnant women
nursing women
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Itoh |
Organization
Oita University Hospital
Division name
Department of Clinical Pharmacy
Zip code
Address
Hasama-machi, Oita 879-5593, Japan
TEL
097-586-6101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Suzuki |
Organization
Oita University Hospital
Division name
Department of Clinical Pharmacy
Zip code
Address
Hasama-machi, Oita 879-5593, Japan
TEL
097-586-6113
Homepage URL
y-suzuki@oita-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacy, Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Oita University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2012 | Year | 02 | Month | 27 | Day |
Last modified on
| 2013 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008706
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
