齐多夫定片剂人体生物等效性研究

    Bioequivalence of zidovudine tablets and capsules in healthy volunteers

    • 摘要: 目的:研究齐多夫定片剂与胶囊在健康人体的生物等效性。方法:20名健康志愿者采用双周期交叉试验,单剂量空腹口服齐多夫定片剂和胶囊剂各300mg,HPLC法测定其血清中齐多夫定浓度,血药浓度-时间数据经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果:齐多夫定片剂与胶囊的主要药代动力学参数分别为:t1/2(0.909±0.308)h和(0.987±0.234)h、Cmax(1.723±0.870)μg/ml和(1.457±0.578)μg/ml、Tmax(0.90±0.69)h和(0.80±0.41)h、AUC0-8h(2.302±0.503)μg·h-1·ml-1和(2.361±0.567)μg·h-1·ml-1。片剂与胶囊比较相对生物利用度为(100.8±25.8)%。结论:齐多夫定片剂与胶囊具有生物等效性。

       

      Abstract: Objective: To investigate the bioequivalence of zidovudine tablets and capsules in healthy volunteers.Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross-over design.The concentration of zidovudine in serum was determined by HPLC,and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics program.Results: The pharmacokinetic parameters of zidovudine tablets and capsules were as follows:t1/2(0.909±0.308) h and(0.987±0.234) h,Cmax(1.723±0.870) μg/ml and(1.457±0.578) μg/ml,Tmax(0.90±0.69) h and(0.80±0.41) h,AUC0-8h(2.302±0.503) μg·h-1·ml-1 and(2.361±0.567) μg·h-1·ml-1.The relative bioavalibility of zidovudine tablets was(100.8±25.8)%.Conclusions: The statistical analysis shows that the test and reference preparation are bioequivalent.

       

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