RelatiVe bioavailability of gatinoxacin methane-sulfonate capSUles versus tablets in healthy male volunteers

Objective: To assess the relative bioavailability of gatifioxacin methane-sulfonate capsules versus tablets. Methods: 24 healthy male volunteers were randomized orally to receive a single crossover dose of either 400mg gatifloxacin capsules or tablets (400mg/each). The plasma gatifloxacin concentrations at certain timepoints after the administration of the gatifloxacin were measured using HPLC. The pharmacokinetic parameters of both gatifoxacins were evaluated using 3P97 program. Results: Ceneralized plot of gatifoxacin concentration versus time showed drug distribution and equilibration for a two-compartment model. No statistical difference of the gatifoxacin capsules versus tablets was found in the pharmacokinetie profiles, i. e. , T_(max) (1.16± 0.40) versus (1.10±0.40)h; C_(max)(3.91±0.61) versus (3.85±0.83)mg·L~(-1); t_(1/2) (6.77±1.65 ) versus (7.28±1.20) h; AUC_(0-t)(28.23±4.77) versus (26.88±6.54)mg·h·L~(-1). Conclusion: The relative bioavailability of the gatifloxacin capsules was 105.4 %.