Assessment on pharmacokinetics and bioavailability of gatifloxacin mesylate capsules in healthy volunteers

AIM: To study the pharmacokinetic parameters and bioavailability of gatifloxacin mesylate capsules. METHODS: An open, randomized, two period crossover study was conducted in 18 healthy volunteers. Concentrations of gatifloxacin in plasma were assayed by HPLC after a single oral dose of 400 mg of the tested capsules or the referenced tablets. The main pharmacokinetic parameters [ AUC (0-24h) , C max and T max ] were analyzed by two one sided t test. RESULTS: The concentration time curve after medication conformed to one compartment open model with a first order absorption. T max , C max and AUC (0-24h) of the tested capsules and the referenced tablet were(1.51± 0.39) and (1.54±0.40) h, (3.48±0.84) and (3.43± 0.96) mg·L -1 ,(34.51±8.49) and (33.04±10.25)mg· h· L -1 respectively. The relative bioavailability of the tested capsules tothe referenced tablets was 107.4%. CONCLUSION: The gatifloxacin mesylate has characteristic of quick absorption, high peak concentration in plasma and longer mean retention time; The result of statistical analysis showed that two formulations were bioequivalent ( P 0.05).