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.%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荆和参比制荆各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(Tman)分剐为(3.56±0.51)h和(3.56±0.51)h,峰浓度(Cman)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(3177.57±362.55)ng/(h·mL)和(3223.84±446.14)ng/(h·mL),0～∞药时曲线下面积(AUC0～∞)分别为(3315.42±387.57)ng/(h·mL)和(3372.50±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.
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