Healthy male subjects
Conditions
Interventions
Initial dose: Midazoram I.v. 0.01mg/kg BW Midazoram i.v. will be escalated with 0.01mg/kg BW if matched with criteria
Sponsors
Showa University School of Dentistry Department of Comprehensive Dentistry
Showa University School of Dentistry Department of Clinical Cariology and Esthetic Dentistry Division
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Subjects are competent to cosent,Keep the rules of the study and are able to report self-codition. 2.Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Exclusion criteria
Exclusion criteria: 1.Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study(such as drug poisoning,alcoholism,and the disease of heart,liver,kidney,lungs,eye,blood etc) and who is taking any drugs (including health supplements). 2.smokers. 3.Any history for drug allergy. 4.Subjects who are taking in too much alcohol. 5.Subjects who are nocturnal life. 6.Subjects within three months after the participation to other clinical traials. 7.Subjects who are inadequate for enrollment judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The anesthetic action after Midazolam i.v.(vomiting reflex,saliva production, mouth open) 2.The sedative action after Midazolam i.v.(subjective evaluation:VAS,objective evaluation:auditory evoked potential) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety assessment (pulse oximeter:SpO2, vital measurement,adverse event) 2.Plasma concentration of midazoram. | — |
Countries
Japan
Contacts
Public ContactNaoki UCHIDA
Showa University School of Medicine Department of Clinical Pharmacology
Outcome results
None listed