儿科药学杂志2011，Vol.17Issue(1)：28-30,3.
罗红霉素胶囊人体生物等效性研究
Bioequivalence of Roxithromycin Capsule in Healthy Volunteers
曾朝英 1秦剑 1周远大 2何海霞 2李娟2
作者信息
- 1. 重庆市中药研究院,重庆,400065
- 2. 重庆医科大学附属第一医院,重庆,400016
- 折叠
摘要
Abstract
Objective: To study the bioequivalence and pharmacokinetics of roxithromycin capsules in 20 healthy male volunteers. Methods: A single dose of 300 mg of roxithromycin capsules were administered to 20 volunteers with a randomized, 2-way crossover design and the serum concentrations of roxithromycin were determined by microbiological assay. The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioequivalence was evaluated. Results: The t1/2β, Cmax, Tmax and AUC0-t of two roxithromycin capsules were (10. 41 ±6. 28) hand (12.50 ±6.40) h, (7. 19 ±2.72)μg/mL and (7.31 ±2.38) μg/mL, (2.80 ±1.21) h and (2.52 ±0.91) h, (67.72 ±32.92) μg ? h ? mL-1 and (69.21 ±31.38) μg ? h ? mL-1 , respectively. The relative bioavailability of test capsules were (97.85 ±14.19) ％. Conclusions; Both roxithromycin capsules are bioequivalent.关键词
罗红霉素胶囊/药动学/生物等效性分类
医药卫生引用本文复制引用
曾朝英,秦剑,周远大,何海霞,李娟..罗红霉素胶囊人体生物等效性研究[J].儿科药学杂志,2011,17(1):28-30,3.
