Relative bioavailability and bioequivalence of famciclovir tablets in healthy volunteers

Objective: To study the relative bioavailability and bioequivalence of famciclovir tablets in healthy volunteers.Methods: A single oral dose of 0.5 g famciclovir(test or reference tablets) was administered to 18 healthy volunteers in a randomised crossover study.The concentrations of penciclovir in plasma were determined by HPLC.The pharmacokinetic parameters were calculated,and the relative bioavailability and bioequivalence of two tablets were evaluated by DAS program.Results: After single doses of test and reference tablets,the pharmacokinetic parameters of penciclovir were as follows: Cmax,(3.05±0.73) and(3.16±0.99) mg·L-1;Tmax,(1.03±0.47) and(1.15±0.62) h;AUC0~12,(9.11±2.75) and(9.53±2.68) mg·h·L-1;AUC0~inf,(9.49±2.98) and(9.89±2.76) mg·h·L-1,respectively.The 90% confidential intervals of AUC0~12,AUC0~inf and Cmax of test tablets were 87.7%~103.7%,87.9%~103.8% and 91.4%~106.4%,respectively.Conclusion: The relative bioavailability is(97.9±22.6)%;the two famciclovir tablets are bioequivalent.