PHARMACOKINETICS OF MIRTAZAPINE FROM ORALLY-ADMINISTERED TABLETS - INFLUENCE OF A HIGH-FAT MEAL

The effect of a high-fat meal on the pharmacokinetics of mirtazapine w as studied in 19 healthy normal young male volunteers. In a randomized two-period crossover study, each volunteer received an oral dose of 1 5 mg of mirtazapine in the form of tablets, in the fasting state and a fter a high-fat meal, with a washout period of 14 days between the two doses. Serial blood samples were taken and pharmacokinetic parameters calculated and statistically analyzed from mirtazapine plasma levels. The extent of absorption of mirtazapine, as measured by the area unde r the plasma level versus time curve, was found to be equivalent for t he fasting and the fed state. Food intake was shown to have no influen ce on the elimination of mirtazapine, as measured by its elimination h alf-life. The rate of mirtazapine absorption, as measured by the peak level (C-max), was not altered by food. The peak time (t(max)), howeve r, in subjects in the fed state showed an increase: the 90%-confidence interval for the median difference ranged from 0.25 to 1.25 h. This w as the only effect of food found in this study. It is considered to be of no clinical consequence.