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Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe
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) a...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177519/ https://www.ncbi.nlm.nih.gov/pubmed/30323643 http://dx.doi.org/10.2147/CEG.S138580 |
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author | Kukulka, Michael Nudurupati, Sai Perez, Maria Claudia |
author_facet | Kukulka, Michael Nudurupati, Sai Perez, Maria Claudia |
author_sort | Kukulka, Michael |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6177519 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-61775192018-10-15 Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe Kukulka, Michael Nudurupati, Sai Perez, Maria Claudia Clin Exp Gastroenterol Original Research 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. Dove Medical Press 2018-10-05 /pmc/articles/PMC6177519/ /pubmed/30323643 http://dx.doi.org/10.2147/CEG.S138580 Text en © 2018 Kukulka et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Kukulka, Michael Nudurupati, Sai Perez, Maria Claudia Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title | Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title_full | Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title_fullStr | Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title_full_unstemmed | Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title_short | Bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
title_sort | bioavailability of dexlansoprazole delayed-release capsule granules when administered via nasogastric tube or orally via syringe |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177519/ https://www.ncbi.nlm.nih.gov/pubmed/30323643 http://dx.doi.org/10.2147/CEG.S138580 |
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