关键词: font-size:medium, ">头孢氨苄胶囊；中国健康受试者；药代动力学；生物等效性

Abstract: Objective： To evaluate the bioequivalence of two kinds of cefalexin capsules in China healthy subjects. Methods：This was a single-center′ randomized′ open-label ′single-dose′ two-period′ cross-over pharmacokinetic study. A total of 24 subjects in fasted and 24 subjects in a fed state were given single oral dose of test and reference preparation of cefalexin capsule(each 250mg)，respectively. The concentration of cefalexin in human plasma was measured by LC-MS/MS. Main pharmacokinetic parameters were calculated by using WinNonlin 6.3 software. Results：The main pharmacokinetic parameters of cefalexin of the test and the reference preparations were as follows： the fasting state Cmax were（10 600±1 930），（9 950±2 090）ng·L-1. AUC0-t were（17 100±2 470），（16 600±2 600）ng·L-1·h. AUC0-∞ were（17 300±2 570），（16 700±2 680）ng·L-1·h . The fed state were （6 220±1 470），（6 040±1 370）ng·L-1. AUC0-t were（16 900±2 740），（16 500±2 450）ng·L-1·h. AUC0-∞ were （17 100±2 820），（16 700±2 520）ng·L-1·h. The 90% confidential interval of Cmax、AUC0-t and AUC0-∞ of tested formulation in the fasting state were 98.47%-116.50%，101.02%-105.57%，101.09%-105.63%. The fed state were 93.19%-112.83%，100.43%-103.63%，100.83%-103.76%. Conclusion：Two kinds of cefalexin capsules are determined to be bioequivalent.

Key words: font-size:medium, ">Cefalexin capsules； Healthy Chinese subjects； Pharmacokinetics； Bioequivalence