Martin B K, Uihlein M, Ings R M, Stevens L A, McEwen J
J Pharm Sci. 1984 Apr;73(4):437-41. doi: 10.1002/jps.2600730404.
Twelve healthy male volunteers participated in a balanced crossover comparison of a brand-name and generic furosemide formulations. Each treatment was given as a single 40-mg tablet following an overnight fast. Furosemide concentrations in plasma and urine were determined up to 24 h after treatment; urine output and urinary sodium excretion were also measured. In comparison with the brand-name tablets, generic furosemide was significantly less bioavailable. Using a 95% confidence interval approach, generic furosemide gave up to 66% lower maximum furosemide plasma levels, up to 52% less area under the plasma level curve to infinite time, and up to 37% less urinary recovery of furosemide. Comparison of the effect of the two treatments was a less sensitive measurement of bioequivalence. Confidence intervals for differences in urinary output and sodium excretion over the period of maximum effect (0-4 h) were, however, asymmetrical, and pharmacodynamic differences between treatments were significant at the 10% level.
12名健康男性志愿者参与了一项名牌速尿制剂和普通速尿制剂的平衡交叉比较试验。每种制剂在禁食过夜后均以一片40毫克的片剂形式给药。在给药后24小时内测定血浆和尿液中的速尿浓度；同时测量尿量和尿钠排泄量。与名牌片剂相比，普通速尿的生物利用度显著降低。采用95%置信区间法，普通速尿的最大血浆速尿水平降低了66%，血浆水平曲线下至无限时间的面积减少了52%，速尿的尿回收率降低了37%。两种治疗效果的比较是一种对生物等效性不太敏感的测量方法。然而，在最大效应期（0 - 4小时）尿量和钠排泄差异的置信区间是不对称的，治疗之间的药效学差异在10%水平上具有显著性。
