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 s...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.展开更多
文摘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.
