Bioequivalence of Two Oral Formulations of Gatifloxacin Tablets in Healthy Male Volunteers

Objective: The purpose of this randomized, crossover study was to compare the bioavailability of a generic and innovator formulation of gatifloxacin 400 mg tablets under fasting conditions. Methods: Seventeen blood samples per period were collected from 24 healthy, Arab male volunteers over 36 hours, plasma gatifloxacin concentrations were determined by HPLC assay, and pharmacokinetic parameters were determined by the non-compartmental method. Results: Mean ± SD Cmax, Tmax, AUC0Æt, AUC0Æ•, and t1/2 were 4.88 ± 1.02 and 4.88 ± 0.99 μg/mL, 1.19 ± 0.62 and 1.14 ± 0.79 h, 37.81 ± 5.54 and 39.12 ± 5.19 μg.h/mL, 39.68 ± 5.86 and 38.00 ± 5.43 μg.h/mL, and 8.07 ± 0.62 and 8.08 ± 0.75 h for the generic and innovator formulation, respectively. ANOVA revealed significant formulation effect for AUC0Æt and AUC0Æ•. However, the parametric 90% confidence intervals on the mean of the difHammami-vol5no1 3/19/05 11:32 AM Page 73