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- Title
Pharmacokinetics of the Generic Formulation Propofol 1% Fresenius in Comparison with the Original Formulation (Disoprivan 1%).
- Authors
Jungheinrich, C.; Scharpf, R.; Wargenau, M.; Dilger, C.; Bepperling, F.
- Abstract
Objective: To investigate the pharmacokinetic profile of a new formulation of propofol (Propofol 1% Fresenius) compared with the reference product Disoprivan 1% in healthy volunteers. Study design, subjects and methods: In a double-blind, crossover study, 18 healthy volunteers (eight males, 10 females) received intravenous propofol bolus infusions of 2 mg/kg bodyweight within 60 seconds via an antecubital vein. After drug administration, serial blood samples were collected for a period of 12 hours. Concentrations of propofol in plasma were determined by a sensitive, selective and validated high performance liquid chromatography (HPLC) method. Results: The mean ratio of Propofol 1% Fresenius/Disoprivanwith regard to area under the concentration-time curve from 0 to 8 hours post dose calculated according to the log-linear trapezoidal rule was 1.001 and for the maximum concentration was 1.009. The corresponding 90% confidence intervals were 0.891 to 1.125 and 0.822 to 1.238, respectively, both being completely contained in the predefined acceptance range of 80 to 125% according to international guidelines. The infusions were well tolerated. None of the adverse events caused premature study termination and none were of a severe or serious nature. Conclusions: The pharmacokinetic comparison clearly demonstrated bioequivalence of the two formulations. The two emulsions can be used interchangeably.
- Subjects
PHARMACOKINETICS; ANESTHETICS
- Publication
Clinical Drug Investigation, 2002, Vol 22, Issue 7, p417
- ISSN
1173-2563
- Publication type
Article
- DOI
10.2165/00044011-200222070-00001