摘要
目的 评价非那雄胺国产片剂和进口片剂在人体内生物等效性。方法 采用高效液相色谱紫外检测法测定20名健康受试者单剂量po 10 mg非那雄胺国产或进口片剂后,血浆中非那雄胺的浓度。结果 非那雄胺国产片剂和进口片剂的AUC0-24均值分别为(840.63±140.84)和(847.51±166.96)ng·h·mL-1,实测cmax均值分别为(117.17±19.74)和(117.43±18.06)ng·mL-1,实测tmax分别为(1.88±0.48)和(1.95±0.43)h,国产非那雄胺片剂的相对生物利用度为(100.73±15.27)％。结论经统计学分析,供试制剂和参比制剂具有生物等效性。
OBJECTIVE: To evaluate the bioequivalence of domestic finasteride tablet and imported tablet. METHODS: A single oral dose of 10 mg domestic tablet or imported tablet was given to 20 healthy volunteers in a randomized crossover study. The concentrations of finasteride were determined by HPLC method. RESULTS: The main pharmacokinetic parameters of the two products were as follows: AUC0-24 (840.63 ± 140.84) and (847.51 ± 166.96) ng · h · mL-1, cmax (117.17 ± 19.74) and (117.43 ± 18.06) ng · mL-1, tmax (1.88 ± 0.48) and (1.95 ± 0.43)h, respectively. The relative bioavailability of domestic tablet to imported tablet was (100.73 ± 15.27)%. There were no significant differences on the pharmacokinetic parameters between the two preparations (P > 0.05). CONCLUSION: The results demonstrated that the two preparations were bioequivalent.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2004年第7期533-535,共3页
Chinese Pharmaceutical Journal
