Bioequivalence Test of Digoxin Powders Containing a New Formula of Lactose

Bioequivalency of newly formulated digoxin powder containing mainly crystalline lactose, which is expected to improve the fluidity of powder, was compared with that of the previous formula containing non-crystalline lactose.The digoxin concentrations in serum of 8 healthy male volunteers were determined by Stratus Immunoassay System after oral administration of either new or old formulation of digoxin powders in a latin square crossover design.The extent and rate of bioavailability of the both digoxin powders were found to be bioequivalent.It was concluded that both formula had clinically equivalent bioavailability but the power of analysis in this bioequivalency test was lower than the guide-line valve given by the committee on bioequivalency test.