中国临床药理学杂志2011，Vol.27Issue(11)：856-858,870,4.
复方缬沙坦在健康人体的生物等效性
Bioequivalence of compound valsartan tablets in healthy volunteers
许莉 1蒋娟娟 1田蕾 1翟玫 1黄一玲 1刘红 1李一石1
作者信息
- 1. 中国医学科学院、北京协和医学院阜外心血管病医院卫生部心血管药物临床研究重点实验室,北京 100037
- 折叠
摘要
Abstract
Objective To study the bioequivalence of compound valsar-tan tablets in Chinese healthy volunteers after single oral administration. Methods Twenty male healthy volunteers were enrolled in a randomized two - way crossover study. The plasma concentrations of valsatarn and hydrochlorothiazide were determined by the sensitive LC/MS/MS method. Results To valsartan, the main pharmacokinetic parameters of test and reference formulations were as follows; Cmax were (2. 39 ± 1. 28) , (2.61 ±1.23) μg · mL-1; tmax were (3.1 ±1.4), (3. 4 ±0.7) h; t1/2 were (7.5 ±1.8), (7.4 ± 1.6) h; AUC0-t were (16.95 ±8.85), (18. 14 ±9. 06) μg · mL-1 · H. To hydrochlorothiazide, the main pharmacokinetic parameters were as follows; Cmax were (0.40 ± 0. 18 ) , (0.42 ±0.15) μg· mL-1; Tmax were (2. 6 ±1.6), (2. 2 ±1.07) h; t1/2 were (9. 6 ±1.4), (9.8 ±1.8) h; AUC0_t were (2.85 ±1.05), (2. 80 ± 0. 89 ) μg · mL -1 · H. The relative bioavailability of valsatarn and hydrochlorothiazide were (93. 9 ± 20. 3 ) % and (102. 1 ± 22. 2) % , respectively. Conclusion The result demonstrated that two formulations were bioequivalent by analysis of variance, two one - side t test and 90% confidence interval.关键词
复方缬沙坦/氢氯噻嗪/液相色谱-串联质谱法/生物等效性Key words
compound valsartan/ hydrochlorothiazide/ LC - MS/MS/ bioequivalence分类
医药卫生引用本文复制引用
许莉,蒋娟娟,田蕾,翟玫,黄一玲,刘红,李一石..复方缬沙坦在健康人体的生物等效性[J].中国临床药理学杂志,2011,27(11):856-858,870,4.
