In phase II trials oral gemifloxacin 320 mg/day produced bacteriological responses of 91% in patients with acute exacerbations of chronic bronchitis (75R, 76C).

The pharmacokinetics of oral gemifloxacin have been characterized in healthy male volunteers. About 20-30% of the dose was excreted unchanged in the urine. The renal clearance was 160 ml/min on average after single and multiple doses, which was slightly greater than the accepted glomerular filtration rate (77C). There were no adverse effects.

In a crossover, randomized study, 16 fasted volunteers (8 men, 8 women) took single oral doses of gemifloxacin 320 mg and ofloxacin 400 mg on two separate occasions, in order to assess urinary excretion (78c). Urine concentrations of ofloxacin were higher than those of gemifloxacin. There were no adverse effects.

Liver Gemifloxacin was generally well tolerated in a pharmacokinetic study, although one subject was withdrawn after 6 days at 640 mg because of mild, transient rises in AlT and AsT not associated with signs or symptoms (77c).

Gemifloxacin 320 mg od and trovafloxacin 200 mg od have been compared in 571 patients with community-acquired pneumonia in a multicenter, double-blind, parallel-group, randomized study (79C). Gemifloxacin was slightly more effective (88%) than trovafloxacin (81%). Gemifloxacin was well tolerated and the incidence of transient liver function abnormalities was very low.

Infection risk The effect of oral gemifloxacin 320 mg for 7 days on the human intestinal microflora has been investigated in 10 healthy subjects (80c). The numbers of enterobacteria, en-terococci, and streptococci were reduced. No other aerobic micro-organisms were affected. The numbers of anerobic cocci and lactobacilli were reduced. The microflora normalized 49 days after withdrawal. There was no selection or overgrowth of resistant bacterial strains or yeasts.

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