The effect of food on the bioavailability of oral gemifloxacin in healthy volunteers

Abstract The effect of food on the bioavailability of gemifloxacin was investigated at two doses (320 and 640 mg) in healthy male and female volunteers. A total of 21 subjects entered the open label, four-period crossover study. Each subject received single oral doses of 320 and 640 mg in the fasted state and after a high fat meal, on separate dosing occasions in a randomised fashion. There was on average, a 3% (95% CI (0.88,1.07)) and 12% (95% CI (0.79,0.97)) reduction in AUC and a 12% (95% CI (0.76, 1.02) and 14% (0.75, 1.00) reduction in C max after the 320- and 640-mg doses, respectively. The results indicate a minor effect of food on bioavailability of gemifloxacin (320 and 640 mg). Such a reduction in systemic exposure would be considered to be not clinically relevant. T max data were inconclusive but indicated a possible slight delay in T max of, on average, 0.75 and 0.21 h after the 320- and 640-mg doses, respectively. Delays of this magnitude in reaching maximum concentrations are unlikely to be of clinical importance for an antibiotic drug. Both 320 and 640 mg gemifloxacin were well tolerated in fed and fasted states by healthy volunteers. It can be concluded therefore, that gemifloxacin can be taken with and without food.