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Recruitment status Completed
Unique ID issued by UMIN UMIN000007391
Receipt No. R000008706
Official scientific title of the study 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

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Basic information
Official scientific title of the study Pharmacokinetics of mirtazapine and effect on plasma levels of bioactive peptides in healthy japanese.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Hiroki Itoh
Organization Oita University Hospital
Division name Department of Clinical Pharmacy
Address Hasama-machi, Oita 879-5593, Japan
TEL 097-586-6101
Email

Public contact
Name of contact person Yosuke Suzuki
Organization Oita University Hospital
Division name Department of Clinical Pharmacy
Address Hasama-machi, Oita 879-5593, Japan
TEL 097-586-6113
Homepage URL
Email y-suzuki@oita-u.ac.jp

Sponsor
Institute Department of Clinical Pharmacy, Oita University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 02 Month 16 Day
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

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008706


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