Pharmacokinetics and bioavialability of nimesulide dispersible tablet / 中国临床药理学与治疗学

ABSTRACT

Aim To study the pharmacokinetics and bioequivalence of nimesulide dispersible tablet and its normal tablet. Methods 20 healthy volunteers were treated with a single oral dose of domestic nimesulide dispersible tablet or normal tablet (control) in a randomized crossover study and the plasma drug concentration was determined by HPLC. Results The plasma concentration time curve was fitted to the one compartment model. The pharmacokinetic parameters obtained were c max ( 3.91 ? 0.74) ?g ?ml -1 , t (1/2)? ( 3.40 ? 0.78) h , t max ( 3.15 ? 0.67) h , AUC 0～24 ( 31.92 ? 6.36) ?g ?ml?h -1 , there was no significant difference between the active and control groups. The relative bioavailability obtained was ( 96.43 ? 8.41 ) %. Conclusion The pharmacokinetic profile for the 2 tablets was similar so it may be concluded that they are bioequivalent.