Pharmacokinetics and bioequivalence studies of cefteram pivoxil in healthy Chinese volunteers.

Fangmi Wei, Rong Zhu, Wenhui Zhao, Jing Yang, Zheng Cai, Qin Hu

School of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.

European journal of drug metabolism and pharmacokinetics 2009 Jul-Sep

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A simple, sensitive and specific method has been developed for the determination of cefteram in human plasma. Sample preparation was accomplished through protein precipitation with 20% trichloroacetic acid (v/v) and chromatographic separation was performed on a C18 column at 25 degrees C. The mobile phase consisted of methanol-aqueous 20 mM ammonium acetate (18:82, v/v) at flow rate of 1.0 mL/min. Wavelength was set at 235 nm. The lower limit of quantification was 0.04 microg/mL and the assay exhibited a linear range of 0.04-3.2 microg/mL (r=0.9996). The relative recoveries of cefteram from human plasma at three different concentrations were more than 90%. The method was successfully applied to investigate the bioequivalence between two kinds of cefteram pivoxil preparations (test vs reference) in 24 healthy Chinese volunteers. After a single 100 mg dose for the test and reference product, the resulting means of major pharmacokinetic parameters such as AUC(0-t), AUC(0-infinity), Cmax and Tmax of cefteram pivoxil were 4.75 +/- 1.35 vs 4.76 +/- 1.29 microg h/mL, 4.89 +/- 1.36 vs 4.91 +/- 1.29 microg h/mL, 1.65 +/- 0.45 vs 1.73 +/- 0.45 microg/mL and 1.48 +/- 0.59 vs 1.73 +/- 0.45 h, respectively, indicating that these two kinds of preparations were bioequivalent.

Citation

Fangmi Wei, Rong Zhu, Wenhui Zhao, Jing Yang, Zheng Cai, Qin Hu. Pharmacokinetics and bioequivalence studies of cefteram pivoxil in healthy Chinese volunteers. European journal of drug metabolism and pharmacokinetics. 2009 Jul-Sep;34(3-4):157-62