Studies on the pharmacokinetics and bioequivalence of domestic gatifloxacin capsules in healthy volunteers

OBJECTIVE To observe the bioavailability of domestic gatifloxacin capsules and imported tablets.METHOD A single oral dose of 400 mg domestic capsules or imported tablets were given to 20 healthy volunteers in a randomized crossover study. The concentrations of gatifloxacin were determined by HPLC method.RESULTS The main pharmacokinetics of the two products were as following: AUC 0～36 (31.60±5.45) and (30.37±5.74) μg·h·mL -1 , c max (3.32±0.55) and (3.37±0.50) μg·mL -1 , t max (1.65±0.37) and (1.55±0.46) h,respectively.The relative bioavailability of domestic capsules to imported tablets was (104.6± 8.6 )%.CONCLUSION There were no significant difference between the parameters of the two preparations( P 0.05).The results demonstrated that the two preparations were bioequivalent.