Pharmacokinetics and Bioequivalence of Azithromycin Dispersible Tablets in Human
Jian Liu
Abstract
Jian Liu
Abstract
The pharmacokinetics and bioequivalence of azithromycin dispersible tablets were investigated in 20 healthy male volunteers , according to a randomized crossover design. The concentrations of azithromycin in plasma were determined by HPLC-MS method. A C_8 column was used with the mobile phase of methanol-0.02mol/L ammonium acetate (70:30). The pharmacokinetic parameters were C_(max) (472.14±216.37)and (432.96±131.80) ng/ml.t_(1/2) (68.63±12.93) and (70.63±15.61)h, T_(max)(2.18±0.89)and(2.25±0.84)h,AUC_o-144h(4268.52±1252.89) and (4370.32±807.82) ng·ml~(-1)·h for test and reference tablets, respectively. The results of variance analysis and two-side t test showed that two products were bioequivalent. The relative bioavailability was (97.1±22.7) %.
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The pharmacokinetics and bioequivalence of azithromycin dispersible tablets were investigated in 20 healthy male volunteers , according to a randomized crossover design. The concentrations of azithromycin in plasma were determined by HPLC-MS method. A C_8 column was used with the mobile phase of methanol-0.02mol/L ammonium acetate (70:30). The pharmacokinetic parameters were C_(max) (472.14±216.37)and (432.96±131.80) ng/ml.t_(1/2) (68.63±12.93) and (70.63±15.61)h, T_(max)(2.18±0.89)and(2.25±0.84)h,AUC_o-144h(4268.52±1252.89) and (4370.32±807.82) ng·ml~(-1)·h for test and reference tablets, respectively. The results of variance analysis and two-side t test showed that two products were bioequivalent. The relative bioavailability was (97.1±22.7) %.
Key concepts: Bioequivalence, Pharmacokinetics, Bioavailability, Chemistry, Chromatography, Crossover study, High-performance liquid chromatography, Azithromycin