Pharmacokinetics and tolerance of enoxacin in healthy volunteers administered at a dosage of 400 mg twice daily for 14 days.

Twenty-four subjects participated in this placebo-controlled, double-blind study. Eighteen were randomized to receive active enoxacin capsules (400 mg twice daily for 14 days) and the remaining six received placebo therapy. Steady state was reached in four days or less, with an average minimum concentration of 1.25 mg/l and the average concentration achieved 1.5 h after the dose was 3.53 mg/l. Five of 18 (28%) subjects who received active enoxacin and two of six (33%) subjects who received placebo reported adverse events, which were generally mild and of short duration. No rash or pruritus were reported. Haematology, biochemistry and urinalyses revealed no untoward effect.

RCT Entities:   Population Interventions Outcomes