A Randomized, Single Dose Bioequivalence Study of Two Tablet Formulations of Balofloxacin In Healthy Human Subjects Under Fasting Conditions

To compare the bioavailability of two tablet formulations of Balofloxacin 100 mg in adult, male, healthy human subjects under fasting conditions.The study was conducted as an open label, balanced, randomized, two-period, two-sequence, two treatment, single dose cross over study to determine the bioequivalence of two tablet formulations of Balofloxacin 100 mg in 24 healthy, adult, male, human subjects under fasting conditions. Serial blood samples were collected at 0, 0.5, 1.0, 1.50, 2.0, 2.50, 2.75, 3.0, 3.25, 3.50, 3.75, 4.0, 4.50, 4.75, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0h during each study period. A washout period of 7 days was given between two study periods. 90% confidence interval(CI) for the ratio of logarithmic transformed pharmacokinetic parameters Cmax, Tmax, AUC0-t and AUC 0- ∞ were used to determine bioequivalence. The data of 23 subjects was analyzed in the study. Tmax (hrs),  Cmax (µg/ml),  AUC 0-t  and AUC0-∞ (µg.h/ml) for test formulation were 1.174±0.535 , 852.431±361.274, 4682.785±1616.552 and 5375.882±1727.286 and that of reference formulation were 1.033±0.428, 850.238±312.422, 4447.628±1240.125 and 5125.723±1304.619 respectively. The 90% CI for the T/R ratios of  log transformed  Cmax, AUC0-t and  AUC 0-∞ were 89.58%-108.19%, 98.86%-109.88% and 97.70%-110.01% respectively. The two tablet formulations of Balofloxacin 100mg (both test and reference) met the  requisite bioequivalence criteria (80-125%) .