Bioavailability and Bioequivalence of 2 Kinds of Sparfloxacin Capsules in Healthy Subjects

OBJECTIVE: To compare the pharmacokinetics and bioavailability between two kinds of sparfloxacin capsules and to evaluate the bioequivalence of the two preparations.METHODS: A single dose of 200mg test capsule or reference capsule of sparfloxacin was administered by randomized crossover way in 22 healthy male volunteers and the plasma concentrations of the sparfloxacin were determined by HPLC.The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioavailability was evaluated.RESULTS: The concentration-time curves of two preparations fitted two compartment model.The pharmacokinetic parameters of the test preparation vs.the reference preparation were as follows: Cmax:(0.85± 0.23) μ g· mL-1 vs.(0.90± 0.27) μ g· mL-1;tmax:(5.59± 2.28) h and(4.95± 1.17) h;AUC0～ 120:(27.92± 6.09) μ g· h· mL-1 vs.(29.65± 8.49) μ g· h· mL-1;AUC0～ ∞ :(29.95± 6.51) μ g· h· mL-1 vs.(31.74± 9.38) μ g· h· mL-1.The relative bioavailability of test sparfloxacin capsule was(97.47± 18.32) %.CONCLUISION: The test sparfloxacin and the reference one are bioequivalent.