A bioequivalence study of two products of furosemide tablets.

Abstract

Twenty healthy male volunteers participated in a balanced crossover comparison of diusemide versus lasix. Each treatment was given as a single 40 mg tablet following an overnight fast. Furosemide concentration in plasma were determined up to 8 h after treatment. Urine output and urinary sodium excretion was also measured. At the 5% confidence level, no significant difference was found between the area under the plasma concentration-time curves of the two products. The Cmax, tmax, cumulative urine volume, cumulative sodium and potassium electrolytes were found not significantly different for both products. Quality control data including assay, content uniformity, disintegration and dissolution indicated that both products passed the pharmacopoeial requirements, U.S.P. XXII and B.P. 1988. In conclusion, diusemide 40 mg is bioequivalent to the brand name lasix.