Relative bioavailability study of a new medium/long-chain triglyceride emulsion of propofol in beagle dogs

• Published in: Drug research (Stuttgart) Vol. 63; no. 11; p. 568
• Main Authors: Chen, W, Cai, Y-Q
• Format: Journal Article
• Language: English
• Published: Germany 01-11-2013
• Subjects: Animals; Area Under Curve; Biological Availability; Chemistry, Pharmaceutical; Dogs; Emulsions; Propofol - chemistry; Propofol - pharmacokinetics; Therapeutic Equivalency; Triglycerides - chemistry
• ISSN: 2194-9379
• DOI: 10.1055/s-0033-1349125

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 AUC0-T, AUC0-∞, MRT, t1/2 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 AUC0-T and AUC0-∞ were within the regulatory range of 80% to 125%.