Bioequivalence of Pidotimod Granules and Pidotimod Syrup in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the bioequivalence of the domestic pidotimod granules with the imported pidotimod syrup as control.METHODS:20 healthy male volunteers were treated with a single dose(800 mg)of pidotimod granules(test formulation)or pidotimod syrup(reference formulation)by a randomized crossover design,with plasma concentrations of pidotimod determined by HPLC and pharmacokinetic parameters of pidotimod computed,and the bioequivalence between two formulations was evaluated using DAS2.0 program.RESULTS:The pharmacokinetic parameters of the reference formation vs.the test formulation of pidotimod were expressed as followst1/2(2.70?0.80)h vs.(2.62?0.84)h;Cmax(4.04?0.59)?g?mL-1 vs.(3.87 ?0.66)?g?mL-1;tmax(2.28?0.44)h vs.(2.13 ?0.43)h;AUC0～14(22.11?4.20)mg?h?L-1 vs.(23.00?4.25)mg?h?L-1;AUC0～∞(22.85?4.42)mg?h?L-1 vs.(23.83?4.52)mg?h?L-1.The relative bioequivalence of the test formulation as against the control was(106.08?22.05)%.CONCLUSION:The pidotimod granules and pidotimod syrup are bioequivalent.