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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01260142
First received: December 13, 2010
Last updated: May 16, 2011
Last verified: May 2011
History of Changes

December 13, 2010
May 16, 2011
November 2010
February 2011   (final data collection date for primary outcome measure)
• The primary objective of the study is to characterize the PK and PD properties of 3 dose levels of fospropofol disodium in comparison with 3 estimated equivalent dose levels of propofol [ Time Frame: Total duration 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01260142 on ClinicalTrials.gov Archive Site
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A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
A Randomized, Open-Label, Single-Bolus, 2-Period, Multi-Dose Level, 3 Cohort Crossover Design, Pharmacokinetic/Pharmacodynamic Study of Lusedra (Fospropofol Disodium) Injection Compared With Propofol Injectable Emulsion

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Experimental: Arm 1
    Intervention: Drug: Fospropofol disodium, propofol
  • Experimental: Arm 2
    Intervention: Drug: Fospropofol disodium, propofol
  • Experimental: Arm 3
    Intervention: Drug: Fospropofol disodium, propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion

  • Males or females >/= 18 to </= 45 years old
  • Non-smokers for at least 18 months prior to Screening
  • Body Mass Index (BMI) </= 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
  • Subjects 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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260142
E2083-A001-410
Not Provided
Elma Manikan, Eisai Inc
Eisai Inc.
Not Provided
Study Director: Randi Fain Eisai Inc.
Eisai Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP