Studies on the bioequivalence of ribavirin tablet in healthy volunteers

OBJECTIVE To evaluate the bioequivalence between two kinds of ribavirin tablets.METHODS A single oral dose of 1000 mg ribavirin tablet was given respectively to 22 healthy volunteers in an open randomized cross-over test for comparison of relative bioavailability in human.Ribavirin serum concentration was determined by HPLC.RESULTS The main pharmaeokinetie parameters were as follows: t_1/2 of test preparation and reference preparation were 22.36±3.28h and 21.57±2.42h,T_ max were 2.00±0.00h and 1.98±0.11h,C_ max were 0.80±0.12μg·ml~ -1 and 0.85±0.22μg·ml~ -1 ,AUC_ 0～72 were 15.77±3.90μg·h·ml~ -1 and 15.12±2.98μg·h·ml~ -1 ,AUC_ 0～∞ were 17.75±4.47μg·h·ml~ -1 and 16.75±3.42μg·h·ml~ -1 ,respectively.There were no statistical differences of all parameters between two preparations(P0.05).The mean relative bioavailability of test preparation versus reference preparation was 104.71%±16.49% .The test preparation was bioequivalent to reference preparation.CONCLUSION The result of variance analysis and two one-side test showed that the two formulations were bioequivalent.