Pharmacokinetics and relative bioavailability of azithromycin tablets in healthy volunteers
HU Jin-hong
Abstract
HU Jin-hong
Abstract
Objective:To investigate the concentration-time profile and the relative bioavailability of test azithromycin tablets.Methods:A single oral dose of 500 mg azithromycin was given in a randomized,cross-over study in 20 healthy volunteers.Serum concentrations of azithromycin were determined by microbiological assay.Results:Concentration-time profile of the test tablet was well fitted to that of the reference tablets.The main pharmacokinetic parameters of the test and reference tablet were as follows:cmax(468.54±136.53) and(473.37±131.51) ng/mL,tmax(1.98±0.72) and(2.00±0.74) h,t1/2(39.35±8.08) and(41.23±7.94) h,AUC0~144(4 525.84±1 002.73) and(4 723.06±1 018.60) ng·h·mL-1.Conclusion:The results of statistical analysis showed that two formulations were bioequivalent.The relative bioavailability of test tablet is(96.27±10.22)%.
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Objective:To investigate the concentration-time profile and the relative bioavailability of test azithromycin tablets.Methods:A single oral dose of 500 mg azithromycin was given in a randomized,cross-over study in 20 healthy volunteers.Serum concentrations of azithromycin were determined by microbiological assay.Results:Concentration-time profile of the test tablet was well fitted to that of the reference tablets.The main pharmacokinetic parameters of the test and reference tablet were as follows:cmax(468.54±136.53) and(473.37±131.51) ng/mL,tmax(1.98±0.72) and(2.00±0.74) h,t1/2(39.35±8.08) and(41.23±7.94) h,AUC0~144(4 525.84±1 002.73) and(4 723.06±1 018.60) ng·h·mL-1.Conclusion:The results of statistical analysis showed that two formulations were bioequivalent.The relative bioavailability of test tablet is(96.27±10.22)%.
Key concepts: Bioequivalence, Bioavailability, Azithromycin, Cmax, Pharmacokinetics, Pharmacology, Medicine, Chemistry