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.