The Pharmacokinetics and Pharmacodynamics of Two 30-mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets and One 60-mg Dexlansoprazole Delayed-Release Capsule: 1676
Abstract
Introduction: The proton pump inhibitor dexlansoprazole (DEX) is given as a modified release (MR) formulation consisting of 2 types of enteric coated granules within a single capsule. DEX MR capsules are approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), healing of erosive esophagitis (EE), and maintenance of healed EE and relief of heartburn. Some patients are unable or unwilling to swallow capsules; therefore, a 30 mg DEX MR orally-disintegrating tablet (OD) has been developed. DEX MR OD contains 2 types of granules that release drug in a pH-dependent manner, extending DEX plasma concentrations. This study assessed the pharmacokinetics (PK) and pharmacodynamics (PD) of two 30 mg DEX MR OD and one 60 mg DEX MR capsule. Methods: In this phase 1, randomized, multiple-dose, 2-period, crossover study, healthy subjects (18 to 55 years) received two 30 mg DEX MR OD or one 60 mg DEX MR capsule once daily for 5 days. There was a 7-day washout between the last dose in Period 1 and the first dose in Period 2. PD was assessed via 24-hour intragastric pH monitoring starting immediately prior to dose on Days 1 and 5 of each period. Analyses of variance models were fitted to the Days 1 and 5 PD parameters and 90% confidence intervals (CIs) for the difference in the least squares (LS) means of the 2 regimens were computed. PD equivalence was concluded if the 90% CIs were contained within the range of (-12%,…
How strong is the evidence?
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. Reported size: 52 participants or records.
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