THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF DEFLAZACORT

The effect of high- and low-fat meals on the relative bioavailability of deflazacort tablets was investigated in 12 healthy, adult males who were administered 36 mg deflazacort under fasted and fed conditions i n a crossover fashion. Serial plasma samples were drawn up to 24 h pos t-dose and quantified for the active metabolite 21-desacetyl deflazaco rt (DFZ 21-OH) by a rapid and sensitive HPLC method. Following deflaza cort administration with high-fat and low-fat meals and under fasted c onditions, DFZ 21-OH area under the curve to infinity averaged 508.39 +/- 131.70, 510.05 +/- 148.30 and 511.90 +/- 188.16 ng.h/ml. DFZ 21-OH C-max averaged 156.31 +/- 33.31, 156.85 +/- 40.17 and 188.05 +/- 53.3 5 ng/ml for high-fat, low-fat and fasted treatments, respectively. Dif ferences in C-max between the fed versus fasted treatments were statis tically significant (P<0.05). The decrease in C-max under fed conditio ns was accompanied by an increase in mean T-max of approximately 17-85 % compared to fasted conditions. As expected, terminal half-life was n ot affected. These data indicate that co-administration of deflazacort tablets with high-fat and low-fat meals leads to a small decrease in rate but does not affect its extent of absorption.