口服非那甾胺片和非那甾胺胶囊的人体生物等效性研究

目的: 研究非那甾胺片剂和胶囊在健康志愿者体内的生物等效性。方法: 24 名健康男性志愿者随机三交叉给药, 分别单剂量口服15 mg 试验药非那甾胺片剂、胶囊及非那甾胺片剂对照药, 采用WatersOasis?HLB 固相萃取小柱提取, 反相高效液相色谱法测定血药浓度, 计算药代动力学参数及相对生物利用度。结果: 口服15 mg 试验药非那甾胺片剂和胶囊及片剂对照药的主要药代动力学参数T1 2ke分别为4.38±0.90、4.29±0.78 和4.32±0.86 h;T_max 分别为3.04±0.88、2.98±0.89 和2.59±0.86 h, C_max 分别为117.57±19.15、118.59±20.23和124.53±19.77 μg·L^-1;AUC0-18分别为897.57±185.03、871.57±139.25 和837.59±149.05 μg·h·L^-1;AUC_0-∞分别为970.04±211.83、931.51 +151.07 和896.41±164.92 μg·h·L^-1。结论: 试验药非那甾胺片和胶囊与对照药非那甾胺片剂具有生物等效性, 相对生物利用度分别为(107.27±9.86) %和(105.06±12.10) %。

Bioequivalance of single oral administration of finasteride tablet and capsule in healthy volunteers

AIM: To study the bioequivalance of finasteride tablet and capsule in 24 healthy volunteers. METHODS: A reversed-phase high performance liquid chromatography (RP-HPLC) method was established for the determination of the finasteride concentrations in human plasma after a single oral dose administration of 15 mg finasteride tablet and capsule and control finasteride tablet (control group) to 24 healthy volunteers in an open randomized crossover design.RESULTS: The main pharmacokinetic parameters of finasteride tablet group, capsule group and finasteride tablet group were as follows:T1 2 ke were 4.38±0.90, 4.29±0.78 and 4.32±0.86 h;T_max were 3.04±0.88, 2.98±0.89 and 2.59±0.86 h;C_max were 117.57±19.15, 118.59±20.23 and 124.53±19.77 μg·L^-1;AUC0-18 were 897.57±185.03, 871.57±139.25 and 837.59±149.05 μg·h·L^-1;AUC_0-∞ were 970.04±211.83, 931.51±151.07 and 896.41±164.92 μg·h·L^-1, respectively. CONCLUSION: The finasteride tablet and capsule and the control finasteride tablet are bioequivalent.