Pharmacokinetics and Bioequivalence of Nimesulide Orally Disintegrating Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the bioavailability of two nimesulide preparations.METHODS:A total of 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 200 mg nimesulide orally disintegrating tablets(test)or nimesulide tablets(reference).The plasma concentrations of nimesulide were determined by RP-HPLC,and the pharmacokinetic parameters and bioavailability were calculated with DAS program.RESULTS:The main pharmacokinetic parameters of nimesulide test and reference preparations were as followAUC0～24(54.67?18.25)vs.(56.15?15.54)?g?h?mL-1;AUC0～∞(56.38?18.03)vs.(57.63?15.26)?g?h?mL-1;Cmax(7.61?2.72)vs.(7.50?2.19)?g?mL-1;tmax(3.83?1.39)and(3.80?1.28)h.The relative bioavailability of nimesulide or-ally disintegrating tablets as against nimesulide tablet was(98.7?22.9)%.CONCLUSION:Nimesulide test and reference preparations were bioequivalent.