Summary
The effect of food on the pharmacokinetic profile of the nonsteroidal anti-inflammatory drug meloxicam was investigated in 2 open, randomised, crossover studies conducted in 2 different groups of healthy male volunteers. A pilot study assessed the effect of a standardised continental breakfast on the pharmacokinetics of a single oral dose of meloxicam 30mg in 6 volunteers, while the other study investigated the pharmacokinetics of a single oral dose of meloxicam l5mg after a high-fat breakfast in 16 volunteers. The extent of meloxicam absorption was not affected by either the continental or the high-fat breakfast. Maximum plasma drug concentrations tended to be achieved earlier after food, and the onset of absorption was slightly delayed after the high-fat meal. However, none of these changes was considered clinically relevant and bioequivalence was demonstrated for both situations (fasted and after high-fat meal). Disposition parameters such as mean residence time, elimination half-life, total clearance or volume of distribution during the terminal phase did not change. Both doses of meloxicam were well tolerated in the fed and the fasting states. In conclusion, the single dose pharmacokinetics of oral meloxicam were not significantly affected by food, suggesting that the drug may be given with or after meals.
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The authors would like to thank Mrs C. Huber for her excellent performance of the analytical procedures.
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Türck, D., Busch, U., Heinzel, G. et al. Effect of Food on the Pharmacokinetics of Meloxicam after Oral Administration. Clinical Drug Investigation 9, 270–276 (1995). https://doi.org/10.2165/00044011-199509050-00004
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DOI: https://doi.org/10.2165/00044011-199509050-00004