Status:
COMPLETED
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
Lead Sponsor:
Eisai Inc.
Conditions:
Anesthesia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion
- Males or females greater than or equal to 18 or less than or equal to 45 years old
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01260142
Start Date
November 1 2010
End Date
March 1 2011
Last Update
January 27 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710