The Effect of Food on the Bioavailability of Dexlansoprazole From the Dexlansoprazole Orally Disintegrating Tablet Formulation
Abstract
Introduction: The proton pump inhibitor dexlansoprazole (DEX) is a modified release (MR) formulation consisting of 2 types of granules in a single capsule. DEX MR is approved in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, healing of erosive esophagitis (EE), maintenance of healed EE, and relief of heartburn. As some patients are unable or unwilling to swallow capsules, a DEX MR orally-disintegrating (OD) 30 mg tablet, containing 2 types of granules that release drug in a pH-dependent manner, has been developed. The DEX MR OD tablet is placed on the tongue, allowed to disintegrate, and swallowed without water. Here we assess the effect of food on the bioavailability (BA) of DEX from the DEX MR OD 30 mg tablet. Methods: In this phase 1, randomized, single-dose, 2-period, crossover study, healthy subjects (18 to 55 years) received a single oral dose of DEX MR OD 30 mg 0.5 hours after starting a high fat meal or after a 10 hour fast. A 5 day washout separated dosing in each period. Blood samples for determination of plasma pharmacokinetics were collected for 24 hours post-dose in each period. For natural logarithms of maximum observed plasma concentration (Cmax), area under the plasma concentrationtime curve (AUC) from time 0 to time of last quantifiable concentration (AUCt), and AUC from time 0 to infinity (AUC∞), an analysis of variance model was fitted with sequence, period, and regimen as fixed effects and subject…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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