2种非那雄胺片人体等效性研究

 目的　研究进口与国产非那雄胺片(每片1mg)在健康人体内的生物等效性。方法采用反相高效液相色谱法,测定21名健康男性单次交叉po对照及试验制剂20mg后血浆中不同时间点的药物浓度,用3P97程序计算药动学参数并进行等效性检验。结果非那雄胺片和保法止片的药动学参数分别为:AUC_0→tn(1413.9±614.9)和(1450.4±684.5)μg·h·L^-1,AUC_0～∞(1460.3±641.7)和(1499.9±711.6)μg·h·L^-1,t_max(2.86±0.3)和(2.90±0.3)h,ρ_max(216.3±83.4)和(209±83.9)μg·L^-1,t_1/2分别为(2.34±0.5)和(2.29±0.4)h。以保法止片为参比,非那雄胺片生物利用度F_0→tn为(99.64±10.9)%,F_0～∞为(99.20±10.1)%。结论方差分析及双单侧t检验表明/,两种制剂具有生物等效性。

Bioequivalence of finasteride tablets in healthy volunteers

OBJECTIVE To study the phamacokinetics and relative bioavailability, and to evaluate the bioequivalence of finestaride tablets. METHODS 21 male subjects were involved in a two-way crossover trial design, plasma concentrations were determined by HPLC method following a single oral dose of 20 mg finasteride preparation.RESULTS The pharmacokinetic parameters of the test tablets and the reference tablets in plasma were as follows, AUC_0～tn (1 413.9±614.9) and (1 450.4±684.5)μg·h·L^-1 ,AUC_0～∞(1 460.3 ±641.7) and (1 499.9±711.6)μg·h·L^-1,t_max(2.86±0.3) and (2.90±0.3)h,ρ_max(216.3±83.4 and (209±83.9)μg·L^-1,t_1/2(2.34±0.5) and (2.29±0.4)h. CONCLUSION The two kinds of finasteride tablet are of bioequivalence.