泛昔洛韦片在中国健康人体的生物等效性

Bioequivalence of famciclovir tablets in Chinese healthy volunteers

目的评价2种国产泛昔洛韦片在中国健康人体的生物等效性。方法 20名健康男性受试者随机交叉单剂量口服泛昔洛韦片试验药物或对照药物,各500 mg。用高效液相色谱法测定血浆中喷昔洛韦浓度;用DAS 2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价。结果试验药物和对照药物的药代动力学参数:Cmax分别为(2.60±0.53)和(3.50±0.84)mg.L-1;Tmax分别为(0.99±0.45)和(2.50±0.23)h;t1/2分别为(2.52±0.32)和(2.50±0.23);AUC0-t分别为(9.10±1.61)和(9.61±1.70)mg.h.L-1。AUC0-t、AUC0-∞、Cmax的90%可信区间分别为90.7%～99.0%、90.9%～99.6%和70.4%～80.6%。试验药物相对于对照药物的生物利用度F为(95.29±9.85)%。结论试验药物和对照药物生物等效。

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.