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目的:评价国产非诺贝特片与进口非诺贝特胶囊人体生物等效性。方法:采用双周期双交叉试验设计,将24名健康受试者随机平均分为2组,在每个给药周期,单次口服受试制剂或参比制剂非诺贝特200 mg,以高效液相色谱法测定血浆中非诺贝酸的浓度,药-时数据经DAS2.1统计软件处理,计算主要药动学参数,并评价二者的生物等效性。结果:非诺贝特片和非诺贝特胶囊的主要药动学参数分别为:t_(1/2)(18.5±4.3)、(19.3±4.4)h,C_(max)(9.0±3.3)、(8.7±2.8)μg·ml~(-1)、t_(max)(5.3±0.9)、(5.0±0.8)h、AUC_(0-72h)(128.1±37.7)、(134.2±42.1)μg·h·ml~(-1),AUC_(0-∞)(140.1±41.6)、(146.8±97.4)μg·h·ml~(-1)。非诺贝特片的相对生物利用度F_(0-72h)为(91.6±3.4)%,F_(0-∞)为(92.6±2.5)%,受试制剂AUC_(0-72h)和C_(max)的90%可信限分别落在参比制剂的90.4%～102.0%和87.2%～116.8%范围内。结论:2种制剂具有生物等效性。
Objective: To evaluate the bioequivalence of domestic fenofibrate tablets and imported fenofibrate capsules. Methods: A double-cycle, double-crossover trial design was used to divide 24 healthy subjects into 2 groups randomly. Each test period was given a single oral test formulation or 200 mg of fenofibrate as reference preparation, The concentration of fenofibrate in plasma was determined by liquid chromatography. The drug-time data were processed by DAS2.1 statistical software to calculate the main pharmacokinetic parameters and evaluate their bioequivalence. RESULTS: The main pharmacokinetic parameters of fenofibrate and fenofibrate capsules were: t 1/2 (18.5 ± 4.3), (19.3 ± 4.4) h and C max (9.0 ± 3.3) , (8.7 ± 2.8) μg · ml -1, t max (5.3 ± 0.9), (5.0 ± 0.8) h, AUC 0-72h (128.1 ± 37.7), (134.2 ± 42.1) μg · H · ml ~ (-1), AUC_ (0-∞) (140.1 ± 41.6) and (146.8 ± 97.4) μg · h · ml ~ (-1) respectively. The relative bioavailability of fenofibrate was (91.6 ± 3.4)% for F_ (0-72h) and (92.6 ± 2.5)% for F_ (0-∞) max) fell within the range of 90.4% to 102.0% and 87.2% to 116.8%, respectively, of the reference formulation. Conclusion: The two preparations are bioequivalent.