A Study to Assess the Efficacy and Safety of Fospropofol Disodium

NCT01271569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-01-06

No results posted yet for this study

Summary

The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \[BIS\]) and to compare the dynamic properties of PropofolF to those of Propofol.

Conditions

  • Drug Safety

Interventions

DRUG

Fospropofol disodium

Fospropofol disodium: 0.5g

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Jin Liu, MD · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2011-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271569 on ClinicalTrials.gov