delirium
Conditions
Interventions
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).
Sponsors
Department of Pharmacotherapeutics, Division of Clinical Pharmacy, School of Pharmacy, Showa University
Clinical Research Institute for Clinical Pharmacology and Therapeutics Showa University Karasuyama Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters (area under the blood concentration time curve, maximum drug concentration, time of maximum drug concentration, half-life) | — |
Countries
Japan
Contacts
Public ContactNoriko Kohyama
Showa University School of Pharmacy
Outcome results
None listed