Study on pharmacokinetics and relative bioavailabity of nimesulide orally disintegrating tablets

Objective To study the relative bioavailability and the phamacokinetics of nimesulide orally disintegrating tablets.Method A single oral administration 200 mg of nimesulide orally disintegrating tablets were given in 20 healthy male volunteers divided into two groups according to randomized crossover design.Nimesulide concentrations in plasma were determined by HPLC.The pharmacokinetic parameters and relative bioavailability of tested tablets were calculated and compared with that of reference tablets.Result After a single oral administration 200 mg of orally disintegrating tablets and reference tablets,the obtained pharmacokinetic parameters were as follows :t1/2(3.626±1.098)h and(3.369±0.55)h;tmax(3.70±0.80)h and(3.55±0.76)h;Cmax:(8.47±1.86)mg·L-1 and(8.55±2.41)mg·L-1;AUC0~16 h(56.90±12.58)mg·h·L-1 and(54.63±17.35)mg·h·L-1.respectively.The relative bioavailability of tested tablets was 106.62%.No significant differences were found among the main pharmacokinetic parameters(P0.05).Conclusion The two preparations presented bioequivalent.