Title: Pharmacokinetics and bioequivalence of domestic and imported cefpodoxime proxetil preparitions in healthy volunteers
Abstract: Objective To study the pharmacokinetics and bioequivalence of domestic and imported preparations of cefpodoxime proxetil. Methods Plasma concentration of cefpodoxime was determined by microbiologic assay. Twenty-four volunteers were distributed into three groups by latin square design with a single oral dose of 200 mg of domestic cefpodoxime tablet (test) and domestic suspension preparation of cefpodoxime proxetil (test), and imported cefpodoxime tablet(reference). Results The pharmacokinetic parameters of the three preparations were as follow: C max of the two test drugs and one referrence drug were (3.52±0.76), (3.62±0.90) and (3.67±0.58) mg·L -1 respectively, t max were (2.8±0.4), (2.8±0.5) and (2.5±0.5) h respectively,t 1/2 were (2.3±0.3), (2.4±0.3) and (2.4±0.3) h respectively,and AUC 0-t were (19.12±5.08), (19.42±4.59) and (20.15±3.56) mg·h·L -1 respectively. There were no significant differences in C max and AUC 0-t between the three preparations (P0.05). The relative bioavailability of the domestic cefpodoxime tablet was (104.2±21.4)%, and that of domestic suspension preparation of cefpodoxime proxetil was (108.3±16.8)% respectively. Conclusion The two tested preparations were of bioequivalence to the refference preparation.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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