Portal de Periódicos da CAPES

Comparative Bioavailability of Two Furosemide Formulations in Humans

1984; Elsevier BV; Volume: 73; Issue: 4 Linguagem: Inglês

10.1002/jps.2600730404

1520-6017

B. K. MARTIN, M. Uihlein, R. M. J. Ings, Lloyd Stevens, John McEwen,

Statistical Methods in Clinical Trials

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 differeences 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.