Relative Bioavailability Study of a New Medium/Long-chain Triglyceride Emulsion of Propofol in Beagle Dogs

Abstract

The aim of this study was to evaluate the bioequivalence of a new generic formulation of propofol medium/long-chain triglyceride emulsion (test) and the available branded formulation (reference) to comply with regulatory criteria for marketing of the test product in China. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in 6 beagle dogs. Blood samples were collected before dosing and at different time after dosing. Plasma samples were separated and assayed for propofol using a selective and sensitive HPLC method with fluorescence detection. The pharmacokinetic parameters AUC_0-T, AUC_0-∞, MRT, t_1/2 and CL were determined from plasma concentration-time profile of both formulations. The formulations were considered bioequivalent when the 90% CIs of the geometric mean ratios (test:reference) for AUC_0-T and AUC_0-∞ were within the regulatory range of 80% to 125%.

Key words

propofol - HPLC - fluorescence detection - pharmacokinetic parameters

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