Pharmacokinetics and bioequivalence of gatifloxacin soft capsule in healthy volunteers

Objective: To determine the pharmacokinetics and the relative bioequivalence of two gatifloxacin formulations in Chinese healthy volunteers.Methods: Single oral doses of gatifloxacin soft capsule and tablet were given to 18 volunteers in a two-way crossover design to study the bioequivalence.Gatifloxacin concentrations in the plasma were determined by HPLC.Results: The pharmacokinetic parameters of soft capsule and tablet were as follows: Tmax(1.85±0.60) and(2.08±0.65) h;Cmax(3.556±0.904) and(3.575±0.908) μg·mL-1;t1/2(7.76±1.27) and(7.91±1.26) h;AUC0～t(29.71±7.10) and(32.00±7.67) μg·h·mL-1;AUC0～∞(30.91±7.53) and(33.32±8.04) μg·h·mL-1.The results showed no significant differences between the two formulations(P0.05).The relative bioavailability of gatifloxacin soft capsule was(95.1±16.7) %.Conclusion: The two gatifloxacin formulations are bioequivalent.