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观察２０名男性健康志愿者随机交叉口服单剂量２００ｍｇ国产和进口苯扎贝特片后血药浓度变化，进行药代动力学和相对生物利用度研究；方法：用反相高效液相色谱测定苯孔贝特血药浓度，用３Ｐ８７药代动力学程序计算有关药代动力学参数，其主要药代动力学参数经三因素方差分析；结果：国产和进口苯扎贝特片的血药浓度一时间曲线均符合口服吸收一室模型，主要药代动力学参数Ｔｍａｘ分别为２．３８±０．８９ｈ和２．１６ ± ０．７９ ｈ， Ｃｍａｘ分别为６．２２ ±１．３０ｍｇ·Ｌ－１和６．５７ ±１．２３ ｍｇ·Ｌ－１， Ｔ１／２分别为１．６７±０．４３ｈ和１．４９ ± ０．３５ｈ，Ａ ＵＣ０－１２分别为２０．３２±３．９８ ｍｇ·ｈ·Ｌ－１和１９．８０±３．６５ｍｇ·ｈ·Ｌ－１；两种制剂的主要药代动力学参数均无显著性差异（Ｐ＞０．０５）；结论：以进口片为标准参比制剂，国产片的相对生物利用度为１０２．６ ± ８．３％，双单侧ｔ检验结果提示，两种制剂生物等效。
To observe the pharmacokinetics and relative bioavailability of 20 Chinese healthy volunteers after randomized crossover oral administration of 200 mg domestic and imported bezafibrate tablets at randomized crossover point.Methods: Concentration of blood concentration of the Kombat, using 3P87 pharmacokinetic program to calculate the relevant pharmacokinetic parameters, the main pharmacokinetic parameters by three-factor analysis of variance; Results: domestic and imported bezafibrate tablets plasma concentration The time curves were consistent with the oral absorption of a compartment model, the main pharmacokinetic parameters Tmax were 2.38 ± 0.89h and 2.16 ± 0.79h, Cmax were 6.22 ± 1.30mg · L-1 And 6.57 ± 1.23 mg · L-1, T1 / 2 was 1.67 ± 0.43 h and 1.49 ± 0.35 h, respectively, and UC0-12 was 20.32 ± 3.98 mg · h · L-1 and 19.80 ± 3.65 mg · h · L-1, respectively. The main pharmacokinetic parameters of the two formulations were not significant (P> 0.05). CONCLUSION: The relative bioavailability of domestic tablets was 102.6 ± 8.3% with imported tablets as reference standard. The results of double unilateral t-test showed that the two formulations Bioequivalent.