论文部分内容阅读
目的评价两种氯沙坦/氢氯噻嗪(50 mg/12·5 mg)复方片剂在中国男性健康志愿者体内的生物等效性。方法本研究采用随机、开放、双周期交叉设计,洗净期为7天。20名男性健康志愿者先后单剂量口服氯沙坦/氢氯噻嗪(50 mg/12·5 mg)受试及参比制剂。血药浓度由已确证的HPLC-ESI-MS法测定。结果双单侧检验结果显示,氯沙坦的AUC0-12及Cmax的90%置信区间分别为86% -112%及89% -134%,氢氯噻嗪分别为85% -100%及75% -102%,均在中国药典所规定的可接受范围内。结论两种速释氯沙坦/氢氯噻嗪复方片剂生物等效。
Objective To evaluate the bioequivalence of two losartan / hydrochlorothiazide (50 mg / 12.5 mg) compound tablets in Chinese male healthy volunteers. Methods This study used a randomized, open, two-cycle crossover design with a washout period of 7 days. Twenty male healthy volunteers received a single oral dose of losartan / hydrochlorothiazide (50 mg / 12.5 mg) and control. Plasma concentration was determined by a validated HPLC-ESI-MS method. Results The two-sided test showed that the 90% confidence intervals of AUC0-12 and Cmax for losartan were 86% -112% and 89% -134%, respectively, and those for hydrochlorothiazide were 85% -100% and 75% -102% , Are in the Chinese Pharmacopoeia within the acceptable range. Conclusions The two immediate-release losartan / hydrochlorothiazide tablets are bioequivalent.