阿奇霉素胶囊及片剂的生物等效性研究

目的:研究阿奇霉素胶囊及片剂在正常人体内的相对生物利用度和生物等效性。方法:采用3×3拉丁方试验设计,将24名男性健康志愿受试者随机分为3组,分别单次口服1 g阿奇霉素供试制剂与参比制剂。采用HPLC法测定阿奇霉素血药浓度。用DAS药动学程序处理试验数据,并对试验结果进行方差分析和双单侧t检验。结果:阿奇霉素胶囊及片剂供试品和参比品的药时曲线下面积(AUC_(0→T))分别为:(23.27±4.52)μg·h·ml~(-1),(23.33±5.76)μg·h·ml~(-1),(23.31±7.70)μg·h·ml~(-1);AUC_(0→∞)分别是(31.25±5.13)μg·h·ml~(-1),(30.59±6.54)μg·h·ml~(-1),(29.78±8.15)μg·h·ml~(-1);达峰时间(t_(max))分别为:(2.17±0.38)h,(2.03±0.55)h,(2.21±0.48)h;达峰浓度(C_(max))分别为:(1.260±0.109)μg·ml~(-1),(1.310±0.138)μg·ml~(-1),(1.298±0.087)μg·ml~(-1)。阿奇霉素胶囊及片剂的相对生物利...

Study on Bioequivalence of Azithromycin Capsules and Tablets in Healthy Volunteers

Objective:To investigate the bioequivalence and relative bioavailability of azithromycin capsules and tablets in healthy volunteers.Method:The 3×3 Latin design was used,24 healthy male volunteers were randomly divided into 3 groups.A single oral dose(1 g of either test or reference preparation) was administered to each volunteer.Azithromycin concentration in plasma was detected by HPLC.The experiment data was calculated with DAS program.The results were analyzed by ANOVA and two one-side test.Result: AUC_(0...