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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。
Objective: To compare the bioequivalence of two azithromycin tablets. Methods: Eighteen healthy male volunteers were enrolled in this study. The two-phase crossover study was conducted. Two kinds of azithromycin tablets were orally administered. The blood concentration was determined by Microbiological Plate Assay. Pharmacokinetic parameters were calculated by 3p97 and bioequivalent Sexual evaluation. Results: The main pharmacokinetic parameters of two azithromycin tablets were as follows: cma (x1.21 ± 0.56), (1.25 ± 0.62) μg · mL-1, tma (x1.94 ± 0.64) and (2.44 ± 1.15) AUC0 ~ 144 (h11.33 ± 7.49), (11.61 ± 7.15) μg · h · mL-1, the relative bioavailability of the test preparation was (97.59 ± 12.72)%. Conclusion: Two kinds of azithromycin tablets have bioequivalence by means of analysis of variance and double unilateral t test.