EFFECT OF FOOD ON THE PHARMACOKINETICS OF MELOXICAM AFTER ORAL-ADMINISTRATION

The effect of food on the pharmacokinetic profile of the nonsteroidal antiinflammatory drug meloxicam was investigated in 2 open, randomised , crossover studies conducted in 2 different groups of healthy male vo lunteers. A pilot study assessed the effect of a standardised continen tal breakfast on the pharmacokinetics of a single oral dose of meloxic am 30mg in 6 volunteers, while the other study investigated the pharma cokinetics of a single oral dose of meloxicam 15mg after a high-fat br eakfast in 16 volunteers. The extent of meloxicam absorption was not a ffected by either the continental or the high-fat breakfast. Maximum p lasma drug concentrations tended to be achieved earlier after food, an d the onset of absorption was slightly delayed after the high-fat meal . However, none of these changes was considered clinically relevant an d bioequivalence was demonstrated for both situations (fasted and afte r high-fat meal). Disposition parameters such as mean residence time, elimination half-life, total clearance or volume of distribution durin g the terminal phase did not change. Both doses of meloxicam were well tolerated in the fed and the fasting states. In conclusion, the singl e dose pharmacokinetics of oral meloxicam were not significantly affec ted by food, suggesting that the drug may be given with or after meals .