摘要
目的评价氯沙坦钾胶囊与片剂(抗高血压药)在健康人体的生物等效性。方法用随机交叉试验设计,20名健康志愿者分别单剂口服氯沙坦钾受试制剂和参比制剂50mg,测定其血药浓度并进行生物等效性的检验。结果受试制剂和参比制剂的Cmax分别为(317.42±217.05),(295.57±132.16)ng·mL-1;tmax分别为(1.17±0.67),(1.27±0.73)h;AUC0-t分别为(637.63±379.83),(591.05±300.77)ng·h·mL-1,2制剂比较无显著性差异。结论氯沙坦钾胶囊与氯沙坦钾片为生物等效性制剂。
Objective To evaluate the bioequivalenee of test and reference losartan potassium formulations in healthy volunteers. Methods A single oral dose of 50 mg test or reference preparation was administrated to 20 healthy volunteers in a randomized cross - over study. The pharmaeokinetie parameters were calculated. Results For losartan test （its capsule） and reference （its tablet） formulations, Cmax were （317.42 ± 217.05） ng · mL^-1 and （295.57 ± 132. 16） ng · mL^-1, tmax were （1.17±0.67） h and （1.27 ± 0.73） h, AUC0-12 were （637.63 ± 379.83） ng · mL^-1 and （591.05 -± 300.77） ng ng · mL^-1, respectively. As to these parameters, the analysis of variance （ANOVA） showed no significant difference. Conclusion The test formulation was considered bioequivalent to the reference formulations.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第6期436-439,共4页
The Chinese Journal of Clinical Pharmacology
