Clinical Pharmacological Study of Midazolam

Phase I Study

Abstract

We carried out a Phase I Study of midazolam in healthy Japanese male volunteers and studied the safety of the drug in different 3 doses (0.1, 0.2, 0.3 mg/kg) administered intravenously and 1 dose (0.2mg/kg) intramuscularly.
No remarkable change was seen in either psychosomatic symptoms, vital signs or laboratory tests.
Sedation was observed characteristically in almost every case. Respiratory depression in dose-independent manner was observed in 0.3 mg/kg administered intravenously. Plasma half-life of midazolam, 1.82-2.68 hr, is far shorter than that of diazepam.
The above results confirmed the safety of midazolam in healthy male Japanese volunteers.
Therefore, we conclude that we can proceed to a Phase II Study with this drug.