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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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, safety and tolerability of fospropofol disodium and propofol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Fospropofol; Propofol

Criteria

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