IN-VIVO BIOAVAILABILITY OF A MULTIPARTICULATE MATRIX SUSTAINED-RELEASE THEOPHYLLINE PREPARATION UNDER FED AND FASTED CONDITIONS

The in vivo bioavailability of a novel multiparticulate matrix sustain ed-release theophylline preparation was compared underfed and fasted c onditions. Twelve healthy volunteers participated in the study conduct ed according to a randomized, two-way crossover design. The parameters used for the comparison were: total area under the serum concentratio n-time curve (AUC(0-infinity)), time to reach peak serum concentration (T-max), and peak serum concentration (C-max). No statistically signi ficant difference was observed between the fed and fasted logarithmic transformed values of AUC(0-infinity) and C-max, as well as the fed an d fasted values of T-max. In addition, the 90% confidence interval for the ratio of logarithmic transformed AUC(0-infinity) values of the fe d condition over those of the fasted was calculated to lie between 0.9 0 and 1.04, which is within the bioequivalence limit of 0.80-1.25. The se findings indicate that both the rate and extent of absorption of th e novel preparation were not significantly affected by food, although a lag time in absorption was observed in the fed condition.