A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
NCT ID: NCT01260142
Last Updated: 2017-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2010-11-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1
Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.
Arm 2
Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.
Arm 3
Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.
Interventions
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Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.
Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.
Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.
Eligibility Criteria
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Inclusion Criteria
* Non-smokers for at least 18 months prior to Screening
* Body Mass Index (BMI) less than or equal to 30 Exclusion
* Subjects having a past or current medical history of any respiratory illness including asthma
* Subjects currently taking any medications (birth control will be allowed if the subject has been taking it for at least 12 weeks prior to dosing and during the entire study), including over-the-counter (OTC) medication, within 14 days of Screening
* Subjects with a known or suspected history of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test at Screening and pre-dose at Visit 2 and Visit 3
* Subjectw who are allergic to eggs, egg products, soybeans, or soy products
* Subjects with a positive pregnancy test at Screening or breastfeeding
* Subjects who are unwilling or unable to abide by the requirements of the study
* Subjects who have any condition that would make him/her, in the opinion of the investigator, unsuitable for the study or who, in the opinion of the investigator, are not likely to complete the study for any reason
18 Years
45 Years
ALL
Yes
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Randi Fain
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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E2083-A001-410
Identifier Type: -
Identifier Source: org_study_id
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