摘要
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。
AIM： To compare the bioavailability of the test and reference formulation of secnidazole （2 g） tablets under fasting conditions. METHODS： This bioequivalence study was carried out in 20 healthy male Chinese volunteers according to a single dose, two-sequence, crossover randomized design. Fifteen blood samples per period were collected over 96 h, and plasma secnidazole concentrations were determined by locally validated high performance liquid chromatography （HPLC） assay and pharmacokinetic parameters were analyzed by the non- compartmental and compartmental methods. RESULTS： Plasma concentration-time profiles were adequately described by a one-compartment open model with first-order absorption. The main phannacokinetic parameters of secnidazole test and reference tablets were as follows： tmax were （2.30 ± 1.06） and （2.28 ± 1.10） h, Cmax were （49.63 ± 6.35） and （46.17 ± 4.24） mg/L, t1/2 were （28.84±3.41） and （29.05 ±4.01） h, AUC0-96 were （1832.06 ± 180.15） and （1847.14 ± 204.14） mg· h^-1·L^-1, respectively. The relative bioavailability of test tablets was （99.99 ± 11.92） %. CONCLUSION： The results indicate that the two formulations of secnidazole tablets are bioequivalent in the rate and extent of absorption.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2007年第1期98-102,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
