UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Title of the study (Brief title)	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

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	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

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	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	Toshinori Yamamoto
Organization	Showa University
Division name	School of Pharmacy
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	Noriko Kohyama
Organization	Showa University
Division name	School of Pharmacy
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

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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://jphcs.biomedcentral.com/articles/10.1186/s40780-016-0046-7
Results
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