格列齐特缓释片生物等效性评价

目的评价格列齐特缓释片在人体口服相对生物利用度及生物等效性。方法采用高效液相色谱法（HPLC）测定健康受试者口服格列齐特缓释片后的血药浓度,计算其药动学参数,以方差分析方法对主要药动学参数进行均数的差别检验,以双单侧t检验进行生物等效性判定。结果空腹状态下格列齐特缓释片受试制剂或参比制剂的主要药物动力学参数AUC0-72、AUC0-∞、tmax、Cmax分别为（43.4±6.8）和（43.9±11.0）mg·h·L^-1,（46.9±8.0）和（47.3±12.2）mg·h·L^-1,（6.8±2.8）和（6.4±2.0）h,（2.4±0.6）和（2.4±0.6）mg·L^-1。受试制剂对参比制剂的相对生物利用度为（102.0±18.4）%。方差分析结果表明受试制剂与参比制剂的主要药动学参数之间无显著差异,双单侧t检验结果表明受试制剂AUC0-72及Cmax对数值的90%可信限分别落在参比制剂80%-125%和70%-143%。结论受试制剂与参比制剂为生物等效制剂。

Bioequivalence of gliclazide sustained release tablets

Objective To evaluate the oral bioavailability and bioequivalence of gliclazide sustailued release tablets in healthy volunteers.Methods An HPLC method was used to determine the plasma concentration of gliclazide in healthy volunteers.Gliclazide pharmacokinetic parameters were calculated and evaluated with ANOVA.The bioequivalence ofthe two formulations were evaluated by two one-sidedt-tests.Results The AUC0 -72,AUC0 -∞,tmax,Cmaxof gliclaz-ide test and reference tablets in a state of fasting were（43.4 ±6.8） and（43.9 ±11.0） mg·h·L^-1,（46.9 ±8.0） and（47.3 ±12.2） mg·h·L^-1,（6.8 ±2.8） and（6.4 ±2.0） h,（2.4 ±0.6） and（2.4 ±0.6） mg·L^-1,respectively,and the relative bioavailability was（102.0 ± 18.4） %.No significant differences were found a-mong the main pharmacokinetic parameters of the two preparations by ANOVA,and the two one-sided t-tests showedthat the trial preparation and the reference preparation were bioequivalent.The 90 %confidence intervals of AUC0 -72andCmaxwere within 80 %-125 %and 70 %-143 %,respectively.Conclusion The gliclazide test and reference tab-lets are bioequivalent.