Bioavailability of 2 sparfloxacin preparations in humans

Objective To determine the concentration of sparfloxacin in the human plasma by High Performance Liquid Chromatography(HPLC),and to study its bioequivalence.Methods The pharmacokinetics of sparfloxacin tablets and capsules were determined following a single oral dose of 400 mg given to 20 healthy volunteers in an open randomized crossover study.The sparfloxacin concentrations in the serum were measured by RP-HPLC.The pharmacokinetic parameters were calculated on the basis of one compartment model using 3P97 program.Results The pharmacokinetic parameters,after the volunteers taking a single dose of 400 mg of the trial preparation or the comparison preparation were as follows:tmax was(4.22±1.59) and(5.06±2.13) h;Cmax was(1.46±0.23) and(1.46±0.31) μg·mL-1;AUC0~96 was(50.50±6.78) and(50.82±11.57) μg·h·mL-1;AUC0~∞ was(53.44±7.79) and(54.25±12.96) μg·h·mL-1;and t1/2 was(22.03±4.57) and(23.01±2.94) h respectively.The pharmacokinetic parameters obtained from our studies showed no significant differences between the two products.The relative bioavailability of sparfloxacin capsule to tablet was 102.41%±16.77%.Conclusion The method can determine sparfloxacin in the plasma quickly and correctly.The two preparations are bioequivalent.