Relative Bioavailability Study of Azithromycin Capsules and Tablets in Men

Objective To investigate the pharmacokinetics and bioequivalence of azithromycin capsules and tablets in healthy volunteers. Methods Using 3×3 Latin design,24 healthy male volunteers were randomly divided into 3 groups.a single oral dose 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.Results The relative bioavailability of azithromycin capsules and tablets in the test was 104.1 % ±10.2 % and 99.9 %±9.8 % respectively;AUC0-T of azithromycin of tests and reference preparations were 23.27±4.52 μg·h·ml-1?23.33±5.76 μg·h·ml-1?23.31±7.70 μg·h·ml-1;AUC0→∞ were 31.25±5.13 μg·h·ml-1?30.59±6.54 μg·h·ml-1?29.78±8.15 μg·h·ml-1;Tmax were2.17±0.38 h?2.03±0.55 h?2.21±0.48 h; Cmax were1.260±0.109 μg·ml-1?1.310±0.138 μg·ml-1?1.298±0.087 μg·ml-1. Conclusion The statistic analysis shows that the main pharmacokinetics parameters of the 3 formulas are not significantly different.Azithromycin of tests and reference preparations are bioequivalent.