drugset
drugset / Trial / NCT01260142

A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion

NCT01260142 ↗

Phase 4 Completed 36 enrolled Eisai Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.

Timeline

Start
2010-11
Primary completion
2011-02
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 0.65 mg/kg Intravenous
Subject Propofol Small molecule 1 mg/kg Intravenous
Subject Propofol Small molecule 1.5 mg/kg Intravenous
Subject fospropofol Small molecule 6.5 mg/kg Intravenous
Subject fospropofol Small molecule 10 mg/kg Intravenous
Subject fospropofol Small molecule 15 mg/kg Intravenous

Indications

No indication recorded.