Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe. 2018

Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
Department of Clinical Pharmacology, 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. CONCLUSIONS Systemic exposure to dexlansoprazole was equivalent regardless of administration route. The dexlansoprazole capsule was well tolerated.

UI MeSH Term Description Entries

Related Publications

Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
July 2014, Clinical pharmacology in drug development,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
January 2023, Clinical pharmacology in drug development,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
April 2024, Journal of clinical pharmacology,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
July 2009, Antimicrobial agents and chemotherapy,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
July 2013, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
January 2006, Clinical pharmacokinetics,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
January 2019, Cardiology,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
March 1996, Digestive diseases and sciences,
Michael Kukulka, and Sai Nudurupati, and Maria Claudia Perez
August 2021, Antimicrobial agents and chemotherapy,
Copied contents to your clipboard!