中国临床药理学与治疗学2011，Vol.16Issue(2)：180-184,5.
甲苯磺酸妥舒沙星分散片在健康人体中的生物等效性研究
Bioequivalence of tosufloxacin tosylate tablets in healthy Chinese volunteers
王晓波 1袭荣刚 1郑慧敏 2岳宏 3刘丹1
作者信息
- 1. 中国人民解放军第210医院国家药物临床试验机构,大连116021,辽宁
- 2. 沈阳药科大学药学院,沈阳110016,辽宁
- 3. 大连医科大学药学院,大连116021,辽宁
- 折叠
摘要
Abstract
AIM: To evaluate the bioequivalence of tosufloxacin test tablets and reference tablets in healthy Chinese volunteers. METHODS: Eighteen healthy male Chinese volunteers were enrolled and orally administrated 0.3 g tosufloxacin test tablets or reference tablets, the concentration of tosufloxacin in plasma were determined by HPLC. The pharmacokinetic parameters were calculated with the aid of DAS 2.0 pharmacokinetics software. The bioequivalence of the test and reference tablets were calculated by analysis of variance, two one sided ttest. RESULTS: The pharmacokinetic parameters of tosufloxacin test tablets and reference tablets were as following: t1/2 (5.17 ± 1.96) and (5.13±2.10) h;tmax(0. 89±0.19) and (0. 86± 0.20) h;Cmax(0.53±0.09) and (0.51±0.09) μg/mL;AUC0-24 h ( 1.75 ± 0.67) and ( 1.76 ± 0.66) μg · h · mL-1 ;AUC0→∞ (1. 98±0. 74) and (1. 98±0.76) μg · h · mL-1 ,respectively. The relative bioavailability of two formulations was (101.1± 15.6) ％. CONCLUSION: The results of statistical analysis demonstrated that the two preparations were bioequivalent.关键词
甲苯磺酸妥舒沙星分散片/药动学/生物等效性分类
医药卫生引用本文复制引用
王晓波,袭荣刚,郑慧敏,岳宏,刘丹..甲苯磺酸妥舒沙星分散片在健康人体中的生物等效性研究[J].中国临床药理学与治疗学,2011,16(2):180-184,5.
