Comparative bioavailability of two capsule formulations of ofloxacin in healthy volunteers after a single dose administration

AbstractThe bioavailability of two ofloxacin (OFX) tablet formulations (OTT, test formulation from Laboratorio Atral SA - Portugal, and Tarivid, reference formulation from Hoechst AG - Germany) were compared in 24 (12M, 12F) healthy volunteers who received a single oral dose of 200 mg of each formulation in an open, randomized, two-period crossover fashion with a 14 day washout interval between doses. Plasma samples were obtained over a 24 h interval and OFX concentrations were determined by HPLC with UV detection. From the OFX plasma concentration vs time curves, the AUC[0-24] (area under the concentration vs time curves from 0 to 24 h), AUC[0-α] (area under the concentration vs time curves extrapolated to infinity), Cmax (maximum concentration achieved), tmax (time to achieve Cmax), t1/2 (terminal first order elimination half-life), and elimination constant (Ke) were obtained. All these variables were analyzed using both parametric and non-parametric statistics. The two OFX tablet brands did not show st...