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

Eisai

Status and phase

Completed

Phase 4

Conditions

Anesthesia

Treatments

Drug: Fospropofol disodium, propofol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01260142

E2083-A001-410

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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