Pharmacokinetics and pharmacodynamics of a single bolus of propofol 2% in healthy volunteers.

Abstract:

:This study was undertaken to assess the bioequivalence between a new formulation of propofol 2% and the commercially available product Diprivan. Secondary objectives were to compare the times to onset of and emergence from hypnosis, the hemodynamic effects, and the safety profiles. Twelve healthy male volunteers were included in a randomized crossover study. Subjects were administered a 2-mg/kg single bolus injection of each formulation separated by a 7- to 10-day washout period. Plasma propofol was determined by reversed-phase liquid chromatography with fluorescence detection. Eleven subjects completed the study, and both formulations were considered bioequivalent. There were no serious or severe adverse events. The concentration-time profiles of all the subjects could adequately be described using a three-compartment model. The mean times to cessation of counting out loud (17 vs. 18 s) and to eye opening (245 vs. 244 s) were not statistically different between treatment groups. Moreover, they seem to show some degree of pharmacodynamic bioequivalence, although a higher number of subjects are necessary to unequivocally demonstrate it.

journal_name

J Clin Pharmacol

authors

Abad-Santos F,Gálvez-Múgica MA,Santos MA,Novalbos J,Gallego-Sandín S,Méndez P,Casimiro C,Gilsanz F

doi

10.1177/0091270003251391

subject

Has Abstract

pub_date

2003-04-01 00:00:00

pages

397-405

issue

4

eissn

0091-2700

issn

1552-4604

journal_volume

43

pub_type

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