Phase 4
Completed N=36
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
Anesthesia
Source: ClinicalTrials.gov NCT01260142 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf)) — 16522; 25052; 36629 ug.h/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf)) |
16522; 25052; 36629 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol |
1541; 467; 2368; 661; 3807; 893 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol |
16046; 24473; 36330 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol |
1343; 385; 2009; 578; 3019; 801 | — |
| PRIMARY Maximum Drug Plasma Concentration (Cmax) of Fospropofol |
95.6; 146.3; 207.3 | — |
| PRIMARY Maximum Drug Plasma Concentration of Propofol |
1.5; 8; 2.1; 8.6; 3.1; 9.5 | — |
| SECONDARY Maximal Sedative Effect Using the Bispectral Index (BIS) Score |
70.2; 81.5; 55.4; 65.8; 38.6; 49 | — |
| SECONDARY Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale |
4.1; 4.7; 2.8; 3.9; 0.3; 1.7 | — |
| SECONDARY Relative Bioavailability of Fospropofol and Propofol |
0.684; 0.661; 0.713; 0.694; 0.68; 0.836 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01260142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.