Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility.
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Lee RD, Vakily M, Mulford D, Wu J, Atkinson SN
Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility.
Aliment Pharmacol Ther. 2009 Apr 15;29(8):824-33. doi: 10.1111/j.1365-2036.2009.03979.x. Epub 2008 Jan 20.
- PubMed ID
- 19243357 [ View in PubMed]
- Abstract
BACKGROUND: Dexlansoprazole MR is a proton pump inhibitor with a Dual Delayed Release (DDR) formulation designed to prolong the dexlansoprazole plasma concentration-time profile. The presence of food or time of dosing relative to food may affect dexlansoprazole absorption. AIMS: To evaluate the effect of food on the pharmacokinetics (PK) and pharmacodynamics (PD) of dexlansoprazole following oral administration of dexlansoprazole MR. METHODS: In this open-label, single-dose, randomized, 4-way crossover study, 48 healthy subjects received placebo (day 1) and dexlansoprazole MR 90 mg (day 3) after fasting, 5 or 30 min before a high-fat breakfast, or 30 min after a high-fat breakfast. Intragastric pH (days 1 and 3) and PK (day 3) of dexlansoprazole were assessed over a 24-h interval after each dose. RESULTS: Following administration of dexlansoprazole MR under fasted/fed conditions, mean dexlansoprazole plasma concentration-time profiles generally exhibited two distinct peaks, resulting from the DDR formulation. Increases in dexlansoprazole maximum plasma concentration (12-31%) and area under the plasma concentration-time curve (9-21%) were observed with the fed regimens; however, differences in intragastric pH were not considered clinically relevant. CONCLUSION: Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.
DrugBank Data that Cites this Article
- Food Interactions
Drug Interaction Dexlansoprazole Take with or without food. Dexlansoprazole's dual delayed release formulation allows it to be taken without regard to food in contrast to other PPIs.