title: 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 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%.
authors.affiliation: Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: W
authors.initials: W
authors.lastname: Chen
authors.forename: Y-Q
authors.initials: YQ
authors.lastname: Cai
mesh_terms: D000818:Animals; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D004285:Dogs; D004655:Emulsions; D015742:Propofol / Q000737:chemistry / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D014280:Triglycerides / Q000737:chemistry*
chemical_list: D004655:Emulsions; D014280:Triglycerides; D015742:Propofol