Study on Relative Bioavailability of Gatifloxacin Hydrochloride Capsules

Objective:To invetigate pharmacokinetics and relative bioavailability of two gatifloxacin preparations in healthy male volunteers.Methods:In a randomized crossover study,18 healthy male volunteers were given a single oral dose of 400 mg test gatifloxacin hydrochloride capsules and reference tablets.The concentrations of gatifloxacin in human plasma were determined by a HPLC method with ultra-violet detector.The pharmacokinetic parameters were processed with DAS 1.0 package for statistic analysis.Results:The pharmacokinetic parameters of the test and reference preparations were as follows: c_(max) were(4.29±0.72) and(4.04±0.45)μg/ml;t_(max)were(1.5±0.7) and(1.5±0.6)h,AUC_(0~36h)were(40.26±4.77) and (37.89±4.09)μg·h·ml~(-1);AUC_(0~∞)were(41.69±5.20) and(39.12±4.53)μg·h·ml~(-1);t_(1/2) were(7.1±0.8) and(7.1±0.8)h,respectively.The relative bioavailability of the test capsules was(106.3±6.6)%.Conclusion:There was no significant difference in t_(max),c_(max),AUC_(0~36h)and AUC_(0~∞)between the two preparations.The two preparations were bioequivalent.