Bioequivalence of famciclovir tablets in Chinese healthy volunteers

Objective To evaluate the bioequivalent of test tablet and reference tablet of famciclovir in Chinese volunteers.Method In self-control and two-way crossover design,20 healthy male volunteers were divided into two groups at random.Each subject was given 500 mg of the test tablet and reference tablet of famciclovir respectively at single dose.Plasma concentrations of penciclovir(active metabolin) were determined by HPLC method.The pharmacokinetic parameters were calculated with DAS statistic software,the bioequivalent of famciclovir tablet evaluated as well.Results The main pharmacokinetic parameters of famciclovir test tablet and reference tablet were as follows: Cmax(2.60±0.53),(3.50±0.84) mg·L-1;Tmax(0.99±0.45),(2.50±0.23) h;t1/2(2.52±0.32),(2.50±0.23) h;AUC0-t(9.10±1.61),(9.61±1.70)mg·h·L-1,respectively.The relative bioavailability of famciclovir test tablet was(95.29±9.85)%.Conclusion The test tablet and reference tablet of famciclovir were bioequivalent.