Bioequivalence of Famciclovir dispersible tablets in human body

OBJECTIVE To study the bioequivalence of Famciclovir dispersible tablets and Famciclovir tablets in human body.METHODS According to a paired,cross-over design,20 healthy male volunteers were randomly divided into two groups.A single oral dose of 0.5 g famciclovir either the test dispersant or its reference was given to them.The plasma concentration of famciclovir was determined by HPLC.The pharmacokinetic parameters were calculated by DAS program and the bioequivalence of the two tablets was evaluated.RESULTS AUC_(0→Tn) of test and reference were 13.80±2.73,13.65±2.42 μg·h·ml~(-1);AUC_(0→∞) were 4.62±2.73,14.35±2.28 μg·h·ml~(-1);C_(max) were 3.42±0.67,3.45±0.67 μg·ml~(-1);T_(max) were 1.11±0.31,1.05±0.25 h,respectively.The bioavailability of the test formation was 101.12%±(8.56%.)CONCLUSION The test famciclovir dispersible tablets were bioequivalent to the reference preparation.