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
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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