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在8例健康志愿者中进行国产与进口氧氟沙星片药物动力学和生物利用度研究。随机交叉试验设计单剂量口服400mg,用HPLC测定血药浓度,按非室模型计算,求得2种制剂各项药物动力学参数,无显著性差异(P>0.05),以进口药片为标准(F=1)求得国产药片的相对生物利用度为92.2%。
In 8 healthy volunteers for domestic and imported ofloxacin tablets pharmacokinetics and bioavailability. A randomized crossover study was designed to determine the pharmacokinetic parameters of the two preparations without any significant difference (P> 0.05) by single-dose oral administration of 400 mg of the drug. The plasma concentration was determined by HPLC. The relative bioavailability of domestic tablets (F = 1) was 92.2%.