加替沙星分散片生物等效性研究

目的研究加替沙星分散片在健康志愿者体内的药物动力学特征及相对生物利用度。方法采用双交叉试验设计自身对照试验法,将20名健康志愿者随机分成2组,单次空服加替沙星分散片（受试制剂）或加替沙星片（参比制剂）400mg,采用高效液相色谱法测定其血药浓度。结果试验制剂和参比制剂的达峰时间（Tmax）分别为（1.813±0.949）h和（1.413±0.718）h,峰浓度（Cmax）分别为（3958.814±598.317）ng/mL和（4098.321±838.365）ng/mL,0-t药时曲线下面积（AUC0-t）分别为（42330.694±5478.929）ng·h/mL和（42927.761±5237.192）ng·h/mL。受试制剂的相对生物利用度为（98.9±8.9）%。结论受试制剂加替沙星分散片与参比制剂生物等效。

Study on Pharmacokinetics and Bioequivalence of Gatifloxacin Dispersible Tablets in Healthy Volunteers

Objective To study the pharmaeokinetic parameters and the relative bioavailability of gatifloxaein dispersible tablets （tested） and gatifloxaein tablets （reference） in healthy volunteers. Methods The open, randomized, two-period crossover study was conducted in 20 healthy volunteers. The concentration of gatifloxacin in plasma was assayed by HPLC after a single oral dose of 400 nag test or reference preparation. Results The concentration-time profile of the test tablets was well fitted to that of the reference tablets. The main pharmaeokinetic parameters of the test and reference tablet were as follows： the Tmax values were （1. 813 ±0. 949）h and （1. 413 ±0. 718）h, the Cmax values were （3 958. 814 ± 598.317）ng/mL and （4 098. 321 ±838. 365）ng/mL, the AUC0-t, values were （42 330. 694 ± 5 478. 929）ng.h/mL and （42 927. 761 ±5 237. 192）ng.h/mL. The relative bioavailability of the dispersible tablets was （98.9 ±8.9）%. Conclusion The two preparations are bioequivalent.