Study on the Bioequivalency of Sparfloxacin Lactate Tablet in Man

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of sparfloxacin lactate tablet in healthy subjects for evaluating the bioequivalency.METHODS:10 healthy volunteers took a single dose(400mg)of sparfloxacin lactate tablets and sparfloxacin tablets(as reference drug) alternately,then the plasma concentrations of sparfloxacin were determined with HPLC.The pharmacokinetic parameters were calculated with 3p87 pharmacokinetic program and the bioequivalency was evaluated.RESULTS:The pharmacokinetic parameters of sparfloxacin lactate tablet and sparfloxacin tablet were:T1/2β=(22.05±1.70)h,(22.23±1.77)h;Cmax=(1.80±0.16)μg/ml,(1.74±0.16)μg/ml;Tmax=(4.11±0.68)h,(3.96±0.80)h;AUCo～t=(49.12±4.53)h/(μg·ml),(45.82±5.32)h/(μg·ml) respectively.The relative bioavailability of sparfloxacin lactate tablet was (107.57±8.47)%.CONCLUSION:Sparfloxacin lactate tablet and sparfloxacin(reference drug)were bioequivalent.