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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013853
Receipt No. R000016159
Scientific Title Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Date of disclosure of the study information 2014/05/02
Last modified on 2016/06/08

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Basic information
Public title Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Acronym Pharmacokinetics of mianserin suppository in healthy volunteers
Scientific Title Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Scientific Title:Acronym Pharmacokinetics of mianserin suppository in healthy volunteers
Region
Japan

Condition
Condition delirium
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pharmacokinetics of a single rectal administration of mianserin 30 mg suppository in adult healthy volunteers
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics parameters (area under the blood concentration time curve, maximum drug concentration, time of maximum drug concentration, half-life)
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 A single dose of mianserin 30 mg suppository will be rectally administered
Blood sampling will be conducted 7 times (at pre, 0.5, 1, 2, 4, 8, 24 hours).
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
45 years-old >
Gender Male
Key inclusion criteria Healthy volunteers enrolled this study must be agreement with the following criteria:
1. Age between 20 and 45
2. Male
3. Subjects are competent to consent, keep the rule of this study and are able to report self condition
4. Subjects who are judged eligible by the investigator in several series of medical check
Key exclusion criteria 1. Subjects who have inappropriate medical history (ex., drug abuse, alcoholism, any kind of heart, liver, kidney, lung, eye, blood diseases and digestive system disorder, etc.) or who are ingested medicines during this study.
2. Smoker.
3. Any drug allergy.
4. Subjects who are using excessive alcohol regularly (cannot keep abstinence for study period).
5. Participation in any clinical trial within the last 3 months.
6. Subjects who are inadequate for enrollment judged by the investigators.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Yamamoto
Organization Showa University
Division name School of Pharmacy
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL 03-3784-8221
Email yamagen@pharm.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Kohyama
Organization Showa University
Division name School of Pharmacy
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL 03-3784-8221
Homepage URL
Email noriko-kyb@pharm.showa-u.ac.jp

Sponsor
Institute Department of Pharmacotherapeutics, Division of Clinical Pharmacy, School of Pharmacy, Showa University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinical Research Institute for Clinical Pharmacology and Therapeutics
Showa University Karasuyama Hospital
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 昭和大学附属烏山病院内 昭和大学臨床薬理研究所(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jphcs.biomedcentral.com/articles/10.1186/s40780-016-0046-7
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
2014 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 07 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
2014 Year 04 Month 30 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016159

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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