Relative Bioavailability and Pharmacokinetics of Roxithromycin Dispersive Tablets in Healthy Volunteers

AIM:To study the pharmacokinetics and relative bioavailability of roxithromycin dispersive tablets in healthy volunteers.METHOD:Following oral administrations of a single dose of 250 mg roxithromycin dispersible tablets(formulation A )and conventional tablets (formulation B)to each of 10 healthy male volunteers in a randomized crossover design.The plasma levels of active drug at different times were determined by a microbial assay with Micrococcus luteus CMCC (B) 28001.RESULT:The AUC 0→36 values of formulation A and B obtained were 61.41±13.53 and 57.63±11.29 μg·h/ml,The AUC 0→∞ values were 66.62±17.89 and 62.93±14.62 μg·h/ml;the t max values were 1.10±0.44 and 1.20±0.26 h;the c max values were 7.15±0.18 and 7.37±0.42 μg/ml,and the t 1/2 values were 8.21±2.92 and 8.28±2.46 h respectively.CONCLUSION:The relative bioavailability of roxithromycin dispersive tablets to conventional tablets was (105.9±13.8)%.The two formulations were bioequivalent.