NCT01302353

Phase I Trial of Emulsified Isoflurane

Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adverse Effect of Intravenous Anesthetics

Interventions

Type	Name	Description
DRUG	Emulsified Isoflurane

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-02-24
• Last updated: 2011-02-24

Locations

1 site across 1 country: China