This randomized, double-blind, 2-way crossover study investigated the effect of omeprazole on the pharmacokinetics of gemifloxacin, a novel fluoroquinolone. Thirteen healthy male volunteers received a 320 mg oral dose of gemifloxacin after 4 days of dosing with either omeprazole (40 mg once daily) or matching placebo. Blood was sampled for 48 h after dosing for determination of pharmacokinetic parameters. The mean area under the plasma concentration-time curve extrapolated to infinity (AUC_0–∞) and maximum plasma concentration (C_max) for gemifloxacin were increased by, on average, 10% (90% confidence interval [CI], 0.89, 1.36) and 11% (90% CI, 0.87, 1.43), respectively, when gemifloxacin was given after omeprazole compared with after placebo. Neither the time to C_max (T_max) nor the half-life of gemifloxacin appeared to be affected by administration of omeprazole. There were no clinically relevant changes in adverse events, vital signs or the results of laboratory investigations after co-administration of omeprazole compared with placebo. In view of the modest increase in systemic exposure and the likely maximal increases indicated by the CIs, the effect of omeprazole on gemifloxacin pharmacokinetics is not considered to be clinically significant. Gemifloxacin and omeprazole can therefore be co-administered with no requirement for a dose adjustment.

The new form of sumatriptan is bioequivalent to sumatriptan conventional tablets and is absorbed more quickly than conventional tablets.

This open, randomized, 4-way crossover study investigated the effect of the antacid Maalox^® on the bioavailability of gemifloxacin, a novel fluoroquinolone antimicrobial. Sixteen healthy male volunteers received gemifloxacin, 320 mg p.o., alone, 3 h after Maalox^® administration, or 10 min or 2 h before Maalox^® administration. Blood was sampled for 48 h after dosing to determine pharmacokinetic parameters. Estimates for the differences between regimens and 95% confidence intervals were calculated using the t-test for paired data. The administration of gemifloxacin 10 min before Maalox^® resulted in an average 85% reduction in the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC_0–∞), whereas administration 3 h after Maalox^® produced a decrease in AUC_0–∞, 15% of which was not considered to be clinically significant. The administration of gemifloxacin 2 h before Maalox^® had no notable effect on the gemifloxacin AUC_0–∞ (average increase of 3%). Similar results were seen for the maximum gemifloxacin plasma concentration (C_max). Neither the time to C_max nor the half-life of gemifloxacin were notably altered by the administration of Maalox^® at any time relative to gemifloxacin dosing. There were no clinically important adverse experiences or changes in clinical laboratory parameters during this study. The findings of this study support the dosing recommendation that gemifloxacin can be administered either 2 h or more prior to, or 3 h or more after, the administration of Maalox^®.

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