头孢羟氨苄咀嚼片的人体生物等效性

Bioequivalence of cefadroxil chewable tablets in healthy volunteers

目的:评价头孢羟氨苄咀嚼片与参比片剂在人体内生物等效性。方法:采用随机交叉试验设计,20名健康男性受试者分别口服单剂量受试制剂与参比制剂500mg,HPLC法测定血浆中头孢羟氨苄的浓度,用DAS1.0统计软件计算药动学参数并进行生物等效性评价。结果:受试制剂与参比制剂的Cmax分别为(19.2±2.3)mg.L-1和(18.4±2.7)mg.L-1,tmax分别为(0.95±0.22)h和(1.3±0.4)h,t1/2分别为(1.78±0.14)h和(1.73±0.09)h,AUC0-10分别为(53.3±7.5)mg.h.L-1和(54.0±7.4)mg.h.L-1,AUC0-∞分别为(54.4±7.9)mg.h.L-1和(55.1±7.7)mg.h.L-1。受试制剂相对于参比制剂的生物利用度为(99.0±7.0)%。结论:两制剂具有生物等效性。

OBJECTIVE To evaluate the bioequivalence of cefadroxil chewable tablets and reference tablets in healthy volunteers, METHODS In a randomized crossover study, 20 healthy male volunteers were given a single oral dose of 500 mg test and reference formulations. The plasma concentration of cefadroxil was determined by an HPLC method. The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS 1.0 software. RESULTS The main pharmacokinetic parameters of the test and the reference formulations were as follows： Cmax were （19. 2± 2. 3）mg·L^-1 and （18. 4 ± 2.7） mg·L^-1, tmax were （0. 95 ± 0. 22）h and（ 1.3 -± 0. 4）h, t（1/2） were （1.78 ± 0. 14）h and（ 1.73 ± 0. 09） h, AUC（0→10） were （53.3 ± 7.5）mg·h·L^-1 and（54. 0 ± 7. 4）mg·h·L^-1, AUC（0→∞） were （54. 4 ± 7. 9）mg·h·L^-1 and（55.1 ± 7. 7）mg·h·L^-1 , respectively. The relative bioavailability of the test tablets was （99. 0 ± 7. 0）%. CONCLUSION The two formulations are bioequivalent.