Study on Bioequivalence of 2 Kinds of Ribavirin Preparations in Human Volunteers

OBJECTIVE:To study bioequivalence of 2 kinds of ribavirin preparations.METHODS:In randomized crossover design,the plasma concentration of ribavirin in 20 healthy volunteers was determined by LC-MS after oral administration of Ribavirin effervescent tablet 150 mg(test preparation) and Ribavirin granules(reference preparation),and the major pharmacokinetic parameters were calculated.RESULTS:The main pharmacokinetic parameters of test preparation vs.reference preparation were as follows:t1/2(44.00±8.75)h vs.(44.89±10.44)h;tmax(1.0±0.7) h vs.(0.8±0.2) h;cmax(424.12±133.03)ng·mL-1 vs.(406.09±108.22)ng·mL-1;AUC0～108 h(4 997.59±1 322.31)ng·h·mL-1 vs.(4 921.16±1 030.61)ng·h·mL-1.The relative bioavailability of test tablet was(105.4±37.4)% by AUC0～108 h.The statistical result showed that there was no significant difference between 2 preparations in the t1/2,cmax,tmax,AUC0～108 h.CONCLUSION:The method is specific,sensitive and accurate.The two preparations are bioequivalent.