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.%Aim To evaluate the bioequivalence of two brands of losartan/hydrochlorothiazide (50 mg/12.5 mg) compound tablets in healthy Chinese male volunteers. Methods An open, randomized, single-dose, two-period cross-over study with a wash-out period of 7 d was conducted. Twenty healthy male volunteers were given a single dose 50 mg losartan/12.5 mg hydrochlorothiazide of either test (T) or reference (R) compound tablets, respectively. Blood samples were collected up to 48 h after oral administration. The concentrations of losartan and hydrochlorothiazide in plasma were determined by a validated HPLC-ESI-MS method. Results In the case of losartan, the 90% confidence intervals of two one-side test for percent ratios with a significant level (α) of 0.05 were 86% - 112% for AUC0-12 and 89% - 134% for Cmax, respectively, which were within the interval proposed in the Chinese Pharmacopoeia, 80% - 125% of AUC and 70% - 143% of Cmax, respectively. Similarly, the 90% confidence intervals for percent ratios were 85% - 100% and 75% - 102% for hydrochlorothiazide, both of which fell into the accepted interval. Conclusion Two immediate-release compound tablets of losartan/hydrochlorothiazide are bioequivalent from a statistical standpoint in the extent and rate of absorption from the single-dose study in healthy Chinese male volunteers.
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