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Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study

BACKGROUND/AIMS: Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough...

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Autores principales: Han, Sungpil, Choi, Hee Youn, Kim, Yo Han, Choi, SeungChan, Kim, Seokuee, Nam, Ji Yeon, Kim, Bongtae, Song, Geun Seog, Lim, Hyeong-Seok, Bae, Kyun-Seop
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Editorial Office of Gut and Liver 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9840922/
https://www.ncbi.nlm.nih.gov/pubmed/36317518
http://dx.doi.org/10.5009/gnl220050
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author Han, Sungpil
Choi, Hee Youn
Kim, Yo Han
Choi, SeungChan
Kim, Seokuee
Nam, Ji Yeon
Kim, Bongtae
Song, Geun Seog
Lim, Hyeong-Seok
Bae, Kyun-Seop
author_facet Han, Sungpil
Choi, Hee Youn
Kim, Yo Han
Choi, SeungChan
Kim, Seokuee
Nam, Ji Yeon
Kim, Bongtae
Song, Geun Seog
Lim, Hyeong-Seok
Bae, Kyun-Seop
author_sort Han, Sungpil
collection PubMed
description BACKGROUND/AIMS: Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough in healthy subjects. METHODS: In a randomized, open-label, single-dose, balanced incomplete block crossover study, 24 healthy male volunteers were enrolled and randomized to receive oral tegoprazan (50, 100, or 200 mg) or dexlansoprazole (60 mg) during each of two administration periods, separated by a 7- to 10-day washout period. Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation. RESULTS: All 24 subjects completed the study. Average maximum plasma concentration, area under the plasma concentration–time curve, and mean time with gastric pH >4 and pH >6 for tegoprazan demonstrated dose-dependent incremental increases. All the tegoprazan groups reached mean pH ≥4 within 2 hours, whereas the dexlansoprazole group required 7 hours after drug administration. Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole. Moreover, the dexlansoprazole group presented a comparable acid-suppressive effect with the tegoprazan groups 12 hours after dosing. CONCLUSIONS: All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group.
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spelling pubmed-98409222023-01-30 Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study Han, Sungpil Choi, Hee Youn Kim, Yo Han Choi, SeungChan Kim, Seokuee Nam, Ji Yeon Kim, Bongtae Song, Geun Seog Lim, Hyeong-Seok Bae, Kyun-Seop Gut Liver Original Article BACKGROUND/AIMS: Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough in healthy subjects. METHODS: In a randomized, open-label, single-dose, balanced incomplete block crossover study, 24 healthy male volunteers were enrolled and randomized to receive oral tegoprazan (50, 100, or 200 mg) or dexlansoprazole (60 mg) during each of two administration periods, separated by a 7- to 10-day washout period. Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation. RESULTS: All 24 subjects completed the study. Average maximum plasma concentration, area under the plasma concentration–time curve, and mean time with gastric pH >4 and pH >6 for tegoprazan demonstrated dose-dependent incremental increases. All the tegoprazan groups reached mean pH ≥4 within 2 hours, whereas the dexlansoprazole group required 7 hours after drug administration. Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole. Moreover, the dexlansoprazole group presented a comparable acid-suppressive effect with the tegoprazan groups 12 hours after dosing. CONCLUSIONS: All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group. Editorial Office of Gut and Liver 2023-01-15 2022-11-01 /pmc/articles/PMC9840922/ /pubmed/36317518 http://dx.doi.org/10.5009/gnl220050 Text en Copyright © Gut and Liver. https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Han, Sungpil
Choi, Hee Youn
Kim, Yo Han
Choi, SeungChan
Kim, Seokuee
Nam, Ji Yeon
Kim, Bongtae
Song, Geun Seog
Lim, Hyeong-Seok
Bae, Kyun-Seop
Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title_full Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title_fullStr Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title_full_unstemmed Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title_short Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study
title_sort comparison of pharmacodynamics between tegoprazan and dexlansoprazole regarding nocturnal acid breakthrough: a randomized crossover study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9840922/
https://www.ncbi.nlm.nih.gov/pubmed/36317518
http://dx.doi.org/10.5009/gnl220050
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