The effect of food and an antacid on the bioavailability of dexketoprofen trometamol

This randomized three-way, crossover pharmacokinetic study was performed to determine whether food or an antacid alters the bioavailability of dexketo profen trometamol. A total of 24 healthy volunteers received three single 2 5 mg doses of dexketoprofen trometamol administered either in fasting condi tion, after an antacid (Maalox(R)), or after a high-fat breakfast. Each vol unteer received the three treatments in a randomized order, with a 7-day wa shout period between treatments. Blood samples were taken at regular interv als up to 24 h after dose. Plasma dexketoprofen concentrations were determi ned by HPLC and the main outcome measures were area under curve of concentr ation vs. time (AUC(0-infinity)) maximal plasma concentration (C-max) and t ime to reach maximal concentration (t(max)). Administration of an antacid 1 0 min before dexketoprofen trometamol had no clinically relevant effect on any of the pharmacokinetic parameters. Food did not alter the extent of abs orption of dexketoprofen trometamol, but t(max) was significantly increased and C-max maw significantly decreased compared with the fasting state. In conclusion, we can state that neither antacid nor food has a significant ef fect on the overall bioavailability of dexketoprofen trometamol. Journal of Clinical Pharmacology, 1998;38:41S-45S (C) 1998 The American College of Cl inical Pharmacology.