Unique ID issued by UMIN | UMIN000013853 |
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Receipt number | 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 10:48:36 |
Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Pharmacokinetics of mianserin suppository in healthy volunteers
Pharmacokinetics of mianserin suppository in Japanese male healthy volunteers -a pilot study -
Pharmacokinetics of mianserin suppository in healthy volunteers
Japan |
delirium
Psychiatry |
Others
NO
To investigate the pharmacokinetics of a single rectal administration of mianserin 30 mg suppository in adult healthy volunteers
Pharmacokinetics
Pharmacokinetics parameters (area under the blood concentration time curve, maximum drug concentration, time of maximum drug concentration, half-life)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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).
20 | years-old | <= |
45 | years-old | > |
Male
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
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.
3
1st name | |
Middle name | |
Last name | Toshinori Yamamoto |
Showa University
School of Pharmacy
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
03-3784-8221
yamagen@pharm.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Noriko Kohyama |
Showa University
School of Pharmacy
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
03-3784-8221
noriko-kyb@pharm.showa-u.ac.jp
Department of Pharmacotherapeutics, Division of Clinical Pharmacy, School of Pharmacy, Showa University
none
Self funding
Clinical Research Institute for Clinical Pharmacology and Therapeutics
Showa University Karasuyama Hospital
NO
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)
2014 | Year | 05 | Month | 02 | Day |
Published
http://jphcs.biomedcentral.com/articles/10.1186/s40780-016-0046-7
Completed
2014 | Year | 04 | Month | 15 | Day |
2014 | Year | 05 | Month | 07 | Day |
2014 | Year | 04 | Month | 30 | Day |
2016 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016159
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