賦形乳糖の処方変更に伴うジゴキシン製剤の生物学的同等性試験

概要

論文の詳細を見る
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.
日本医療薬学会の論文
1988-02-20