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Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan

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Abstract
Purpose: Tegoprazan is a potassium-competitive acid blocker (P-CAB) that is designed to treat acidrelated diseases through a fundamentally different mechanism than that of proton pump inhibitors (PPIs). Because PPIs inhibit only activated parietal cell H+/K+ adenosine triphosphatase, stimulation of parietal cells by a meal is necessary for optimal results. In contrast, P-CABs can inactivate proton pumps without acid activation and bind to both activated and inactivated adenosine triphosphatase. This study evaluates the effect of food consumption on the pharmacokinetic and pharmacodynamic properties of tegoprazan after a single oral dose in healthy men.

Methods: In this open-label, 2-period crossover study, 24 healthy men were randomized to 1 of 2 treatment sequence groups: administration of tegoprazan under the fasting condition and administration of tegoprazan under the fed condition. The dosing periods of both sequence groups were separated by a washout period of 7 days. At each dosing period, the participants received a single dose of 200 mg of tegoprazan followed by pharmacokinetic and pharmacodynamic analysis.

Findings: After the oral administration of 200 mg tegoprazan, the C-max was decreased and delayed under the fed condition compared with that of the fasting condition. However, no significant differences were observed in the AUC and the time of gastric acid suppression (inhibition of integrated acidity) during 24 hours. (C) 2021 Elsevier Inc.
Author(s)
한성필최희연김요한남지연김봉태송근석임형석배균섭
Issued Date
2021
Type
Article
Keyword
Food effectGERDpharmacodynamicspharmacokineticstegoprazan.
DOI
10.1016/j.clinthera.2021.06.007
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7696
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2550622385&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Effect%20of%20Food%20on%20the%20Pharmacokinetics%20and%20Pharmacodynamics%20of%20a%20Single%20Oral%20Dose%20of%20Tegoprazan&offset=0&pcAvailability=true
Publisher
CLINICAL THERAPEUTICS
Location
미국
Language
영어
ISSN
0149-2918
Citation Volume
43
Citation Number
8
Citation Start Page
1371
Citation End Page
1380
Appears in Collections:
Medicine > Medicine
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