盐酸左氧氟沙星胶囊的生物等效性研究

Bioequivalence of Levofloxacin Capsule in Healthy Chinese Young Men

目的研究两种盐酸左氧氟沙星胶囊在健康人体内的生物等效性。方法18名男性健康志愿者,随机交叉口服国产盐酸左氧氟沙星胶囊0.2g,HPLC法测血药浓度,用3p97程序求算药动学参数。结果两种国产盐酸左氧氟沙星胶囊的相对生物利用度F0-t为（96.1±9.4）%,F0-∞为（96.5±9.3）%,方差分析和双单侧t检验表明两种制剂主要参数间差异无统计学意义,受试制剂AUC0-t和Cmax的90%可信限分别为参比制剂的91.8%-99.6%和99.8%-103.5%。结论两种盐酸左氧氟沙星胶囊生物等效。

Objective To compare the pharmacokinetics of two domestic levofloxacin capsules. Methods A single oral dose of levofloxacin capsule 0. 2 g was performed on 18 Chinese healthy volunteers in a randomized crossover protocol. The levofloxacin in serum was measured by validated HPLC. Data were analyzed automatically by using 3p97 program on a PC computer. Results The relative bioavailability F0-1 and F0-∞ of the two levofloxacin capsule were （96. 1 ±9.4） % and （96. 5 ± 9. 3 ） %, respectively. Tested with ANOVA and two one - sided t test, the main pharmacokinetic parameters of tested and reference capsules showed no significant differences. The 90% confidential intervals of AUC and Cmax of tested formula were 91.8% -99.6% and 99.8% - 103.5%, respectively. Conclusion The tested levofioxacin capsule showed bioequivalence compared with the reference one.