:Phase I Study
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概要
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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.<BR>No remarkable change was seen in either psychosomatic symptoms, vital signs or laboratory tests.<BR>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.<BR>The above results confirmed the safety of midazolam in healthy male Japanese volunteers.<BR>Therefore, we conclude that we can proceed to a Phase II Study with this drug.
- 一般社団法人 日本臨床薬理学会の論文
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- :Phase I Clinical Trial
- :Phase I Study