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 dexketoprofen trometamol. A total of 24 healthy volunteers received three single 25 mg doses of dexketoprofen trometamol administered either in fasting condition, after an antacid (Maalox), or after a high-fat breakfast. Each volunteer received the three treatments in a randomized order, with a 7-day washout period between treatments. Blood samples were taken at regular intervals up to 24 h after dose. Plasma dexketoprofen concentrotions were determined by HPLC and the main outcome measures were area under curve of concentration vs. time (AUC0-infinity), maximal plasma concentration (Cmax), and time to reach maximal concentration (t(max)). Administration of an antacid 10 min before dexketoprofen trometamol had no clinically relevant effect on any of the pharmacokinetic parameters. Food did not alter the extent of absorption of dexketoprofen trometamol, but t(max) was significantly increased and C(max). significantly decreased compared with the fasting state. In conclusion, we can state that neither antacid nor food has a significant effect on the overall bioavailability of dexketoprofen trometamol.
McEwen
J
J
Drug Development (Scotland) LTD, Ninewells Hospital and Medical School. Dundee.
De Luca
M
M
Casini
A
A
Gich
I
I
Barbanoj
M J
MJ
Tost
D
D
Artigas
R
R
Mauleón
D
D
D000293:Adolescent; D000328:Adult; D000863:Antacids / Q000494:pharmacology*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D018592:Cross-Over Studies; D004347:Drug Interactions; D005260:Female; D018565:Food-Drug Interactions; D006801:Humans; D007660:Ketoprofen / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D013607:Tablets; D014325:Tromethamine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000633:toxicity
D000863:Antacids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D014325:Tromethamine; D007660:Ketoprofen; C118296:dexketoprofen trometamol