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１０名健康男性志愿者采用交叉给药方案，分别单剂量口服２００ｍｇ国产甲磺酸左旋氧氟沙星片及进口左旋氧氟沙星片，进行国产制剂的相对生物利用度研究。用ＨＰＬＣ法测定血清及尿中左旋氧氟沙星药物浓度，血药浓度－时间数据经３Ｐ８７程序自动拟合，符合二室模型。试验结果表明：单次口服２００ｍｇ国产甲磺酸左旋氧氟沙星片与进口左旋氧氟沙星片后，达峰时间分别是１．２５±０．２６ｈ和１．４０±０．２１ｈ，峰浓度分别是２．８７±０．２３ｍｇ·Ｌ－１和２．８４±０．２２ｍｇ·Ｌ－１，０～２４ｈ的药时曲线下面积分别为２１．１５±２．１８ｍｇ·ｈ·Ｌ－１和２１．６９±１．８８ｍｇ·ｈ·Ｌ－１。其主要药代动力学参数经方差分析和双单侧Ｔ检验，无显著性差异（Ｐ＞０．０５），两种制剂具有生物等效性。国产甲磺酸左旋氧氟沙星片的相对生物利用度为９７．９０％。２４ｈ的尿药排泄率为６９．６８％。
Ten healthy male volunteers were given a crossover dosing regimen. A single oral dose of 200mg domestic levofloxacin mesylate tablets and imported levofloxacin tablets, the relative bioavailability of domestic formulations. The concentration of levofloxacin in serum and urine was determined by HPLC method. The plasma concentration-time data were fitted automatically by 3P87 program, which accorded with two-compartment model. The results showed that: a single oral administration of 200mg domestic levofloxacin tablets and imported levofloxacin tablets, the peak time were 1.25 ± 0.26h and 1.40 ± 0.21h, peak Concentrations were 2.87 ± 0.23mg · L-1 and 2.84 ± 0.22mg · L-1, 0 ~ 24h drug under the curve area were 21.15 ± 2.18mg · h · L- 1 and 21.69 ± 1.88 mg · h · L-1. The main pharmacokinetic parameters were analyzed by analysis of variance and double unilateral T test, no significant difference (P> 0.05), two formulations have bioequivalence. The relative bioavailability of domestic levofloxacin mesylate tablets was 97.90%. 24h urinary excretion rate was 69.68%.