In Vivo Bioavailability of a Multiparticulate Matrix Sustained-Release Theophylline Preparation Under Fed and Fasted Conditions

Abstract

The in vivo bioavailability of a novel multiparticulate matrix sustained-release theophylline preparation was compared under fed and fasted conditions. Twelve healthy volunteers participated in the study conducted according to a randomized, two-way crossover design. The parameters used for the comparison were: total area under the serum concentration-time curve (AUC₀), time to reach peak serum concentration (T_max), and peak serum concentration (C_max). No statistically signifcant difference was observed bemeen the fed and fasted logarithmic transformed values of AUCG₀ and C_max as well as the fed and fasted values of T_max In addition, the 90% confidence interval for the ratio of logarithmic transformed AUC₀ values of the fed condition over those of the fasted was calculated to lie between 0.90 and 1.04, which is within the bioequivalence limit of 0.80–1.25. These findings indicate that both the rate and extent of absorption of the novel preparation were not significantly affected by food, although a lag time in absorption was observed in the fed condition