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目的:研究塞克硝唑试验片与参比片的生物利用度,并进行生物等效性评价。方法:20名健康男性志愿者单剂量口服塞克硝唑试验或参比制剂各2 g;采用反相高效液相色谱法测定其血药浓度。结果:人体药动学研究表明,口服塞克硝唑片的药-时曲线符合一级吸收的单房室模型。试验片与参比片的主要药代动力学参数:tmax分别为(2.30±1.06)和(2.28±1.10)h;Cmax分别为(49.63±6.35)和(46.17±4.24)mg/L;t1/2分别为(28.84±3.41)和(29.05±4.01)h;AUC0-96分别为(1832.06±180.15)和(1847.14±204.14)mg.h-1.L-1;相对生物利用度为(99.99±11.92)%。结论:塞克硝唑片两种制剂具有生物等效性。
OBJECTIVE: To study the bioavailability of Secnidazole test strips and reference tablets and to evaluate their bioequivalence. Methods: Twenty healthy male volunteers were given single oral dose of 2 mg of Secnidazole or reference preparations, respectively. The plasma concentrations were determined by RP-HPLC. RESULTS: Human pharmacokinetic studies showed that the drug-time curve of oral Secnidazole tablets conformed to the single-compartment model of primary absorption. The main pharmacokinetic parameters of test and reference tablets: tmax were (2.30 ± 1.06) and (2.28 ± 1.10) h, respectively, and Cmax were (49.63 ± 6.35) and (46.17 ± 4.24) mg / 2 were (28.84 ± 3.41) and (29.05 ± 4.01) h respectively; AUC0-96 was (1832.06 ± 180.15) and (1847.14 ± 204.14) mg · h-1.L-1, respectively; relative bioavailability was (99.99 ± 11.92)%. Conclusion: Secnidazole tablets are bioequivalent.