2种阿奇霉素片的人体生物等效性研究

目的：比较2种阿奇霉素片的人体生物等效性。方法：18名健康男性志愿受试者采用双周期双制剂交叉试验设计,单剂量口服2种阿奇霉素片,用微生物杯碟法测定血药浓度,以3p97计算药动学参数,并进行生物等效性评价。结果：2种阿奇霉素片主要药动学参数分别为：cma（x1.21±0.56）、（1.25±0.62）μg·mL-1,tma（x1.94±0.64）、（2.44±1.15）h,AUC0～144（h11.33±7.49）、（11.61±7.15）μg·h·mL-1,受试制剂的相对生物利用度为（97.59±12.72）%。结论：经方差分析和双单侧t检验,2种阿奇霉素片具有生物等效性。

Bioequivalence of 2 Kinds of Azihromycin Tablets in Healthy Volunteers

OBJECTIVE： To compare the bioequivalence of 2 kinds of Azihromycin tablets in healthy volunteers. METHODS： 2 kinds of Azihromycin tablets were administered by randomized crossover way in 18 male volunteers for 2 periods, and the blood concentrations of azihromycin were determined by microbiological assay. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS： Main pharmacokinetic parameters were as follows： cmax（1.21±0.56）μg·mL-1 and （1.25±0.62）μg·mL-1; tmax（1.94±0.64）h and （2.44±1.15）h; AUC0～144 h（11.33±7.49）μg·h·mL-1 and （11.61±7.15）μg·h·mL-1. The relative bioavailability of test tablets was （97.59±12.72）%. CONCLUSION： Results of variance analysis and t-tests suggest that 2 kinds of Azihromycin tablets are bioequivalent.