Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe

Michael Kukulka,1 Sai Nudurupati,2 Maria Claudia Perez3 1Department of Clinical Pharmacology, Takeda Development Center Americas, Inc., Deerfield, IL, USA; 2Department of Analytical Sciences, Takeda Development Center Americas, Inc., Deerfield, IL, USA; 3Department of Clinical Science, Takeda Development Center Americas, Inc., Deerfield, IL, USA Objective: To assess the effect of route of administration on the bioavailability of dexlansoprazole 60 mg delayed-release capsule granules.Methods: One open-label, Phase I, single-dose, 3-period crossover study was conducted in healthy adults. The bioavailability of Dexilant® (dexlansoprazole) after dexlansoprazole capsule granules were mixed with water and administered via 16 French nasogastric tube or orally via syringe was compared to administration of the intact capsule in the fasted state, swallowed with water. Blood samples were collected before and after dosing to determine dexlansoprazole pharmacokinetic parameter estimates and plasma concentrations.Results: Similar values for area under the plasma concentration–time curve and observed maximum plasma concentration were achieved when the dexlansoprazole 60 mg capsule was administered as the intact capsule or when the granules were mixed with water and administered via nasogastric tube or orally via syringe. The primary endpoints of maximum plasma concentration and area under the plasma concentration–time curve demonstrated bioequivalence when assessing these alternative routes of administration. Most adverse events were rated as mild and were comparable irrespective of administration route.Conclusion: Systemic exposure to dexlansoprazole was equivalent regardless of administration route. The dexlansoprazole capsule was well tolerated. Keywords: TAK-390MR, dexlansoprazole, dual delayed release, pharmacokinetics, proton pump inhibito