非那雄胺片人体药代动力学及生物等效性研究

Pharmacokinetics and Relative Bioequivalence of Finasteride Tablets in Healthy Volunteers

目的研究单剂量口服非那雄胺片后的血药浓度经时过程,并进行生物等效性评价。方法采用自身交叉试验方法,18名健康志愿者分别单剂量口服非那雄胺片受试制剂和参比制剂各30 mg,采用高效液相色谱法测定血浆中药物浓度。结果受试制剂与参比制剂的血药浓度-时间曲线基本一致,主要药代动力学参数达峰时间(Tmax)分别为(3.56±0.51)h和(3.56±0.51)h,峰浓度(Cmax)分别为(549.69±48.98)ng/mL和(549.85±70.02)ng/mL,消除半衰期(t1/2)分别为(4.45±0.54)h和(4.58±0.53)h,0～24 h药时曲线下面积(AUC0-24)分别为(3 177.57±362.55)ng/(h·mL)和(3 223.84±446.14)ng/(h.mL),0～∞药时曲线下面积(AUC0-∞)分别为(3 315.42±387.57)ng/(h.mL)和(3 372.50±473.23)ng/(h·mL),受试制剂的相对生物利用度为(99.11±7.97)%。结论两种制剂具有生物等效性。

Objective To investigate the concentration-time profile and the relative bioequivalence of test Finasteride Tablets.Methods The test and reference tablets with a single oral dose of 30 mg finasteride were given to 18 healthy volunteers respectively,in a randomized,cross-over study.Serum concentrations of finasteride were determined by HPLC.Results The concentration-time profile of the test tablets was well fitted to that of the reference tablets.The main pharmacokinetic parameters of the test and reference tablets were as follows,Tmax were（3.56±0.51）h and（3.56±0.51）h,Cmax were（549.70±48.98）ng/mL and（549.85±70.02）ng/mL,t1/2 were（4.45±0.54）h and（4.58±0.53）h,AUC0-24 were（3 177.57±362.55）ng/（h·mL） and（3 223.84±446.14）ng/（h·mL）,AUC0-∞were（3 315.42±387.57）ng/（h·mL） and（3 372.50±473.23）ng/（h·mL）.The relative bioavailability of tested tablets is（99.11±7.97）%.Conclusion Two preparations were bioequivalent.