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drugset / Trial / NCT01302353

Phase I Trial of Emulsified Isoflurane

NCT01302353 ↗

Phase 1 Completed 78 enrolled Sichuan University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.

Timeline

Start
2010-05
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoflurane Other / unclassified 0.0024 unknown Intravenous
Subject Isoflurane Other / unclassified 0.006 unknown Intravenous
Subject Isoflurane Other / unclassified 0.012 unknown Intravenous
Subject Isoflurane Other / unclassified 0.02 unknown Intravenous
Subject Isoflurane Other / unclassified 0.0301 unknown Intravenous
Subject Isoflurane Other / unclassified 0.0391 unknown Intravenous
Subject Isoflurane Other / unclassified 0.0508 unknown Intravenous
Subject Isoflurane Other / unclassified 0.066 unknown Intravenous
Subject Isoflurane Other / unclassified 0.0859 unknown Intravenous
Subject Isoflurane Other / unclassified 0.1116 unknown Intravenous
Subject Isoflurane Other / unclassified 0.1451 unknown Intravenous
Subject Isoflurane Other / unclassified 0.1886 unknown Intravenous
Subject Isoflurane Other / unclassified 0.2452 unknown Intravenous
Subject Isoflurane Other / unclassified 0.3188 unknown Intravenous
Subject Isoflurane Other / unclassified 0.4144 unknown Intravenous
Subject Isoflurane Other / unclassified 0.5387 unknown Intravenous

Indications

No indication recorded.