BIOEQUIVALENCE OF ORAL AND INTRAVENOUS OFLOXACIN AFTER MULTIPLE-DOSE ADMINISTRATION TO HEALTHY MALE-VOLUNTEERS

The bioequivalence of oral and intravenous ofloxacin was investigated after the administration of multiple doses of 400 mg every 12 h to 20 healthy male volunteers in a randomized, crossover, open-label study. Ofloxacin concentrations in plasma were evaluated after 4 days of oral or intravenous (1-h infusion) dosing with a 3-day wash-out period bet ween regimens. As expected, delivery to the systemic circulation took slightly longer after the oral dosing (time to maximum concentration o f drug in serum of 1.7 h) relative to the 1-h intravenous infusion, bu t the systemic availabilities of ofloxacin by the two routes of admini stration were equivalent (area under the concentration-time curve from 0 to 12 h ratio of 95%). Since previous studies have not demonstrated any change in the bioavailability of ofloxacin in infectious disease patients, this study supports the interchangeability of these dosing r egimens.