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 in a crossover fashion. Serial plasma samples were drawn up to 24 h post-dose and quantified for the active metabolite 21-desacetyl deflazacort (DFZ 21-OH) by a rapid and sensitive HPLC method. Following deflazacort administration with high-fat and low-fat meals and under fasted conditions, 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 Cmax averaged 156.31 +/- 33.31, 156.85 +/- 40.17 and 188.05 +/- 53.35 ng/ml for high-fat, low-fat and fasted treatments, respectively. Differences in Cmax between the fed versus fasted treatments were statistically significant (P < 0.05). The decrease in Cmax under fed conditions was accompanied by an increase in mean Tmax of approximately 17-85% compared to fasted conditions. As expected, terminal half-life was not 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.

RCT Entities:   Population Interventions Outcomes