{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T18:49:39Z","timestamp":1792003779970,"version":"4.4.0"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T00:00:00Z","timestamp":1611187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec><jats:title>Abstract<\/jats:title><jats:p>Tegoprazan, a novel potassium\u2010competitive acid blocker, is used to treat acid\u2010related diseases. However, there is no information on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the marketed dosage of tegoprazan under various meal timings in a fed and fasted state. The study aimed to assess the effect of meal timing on PKs and PDs of tegoprazan 50\u00a0mg after a single administration in healthy male subjects. An open\u2010label, single\u2010dose, three\u2010treatment, three\u2010period crossover study was conducted. A total of 12 subjects were orally administered a single dose of tegoprazan 50\u00a0mg among various conditions: in a fasted state, at 30\u00a0min before or 30\u00a0min after a high\u2010fat meal. PK parameters were estimated by the noncompartmental method. Continuous 24\u2010h intragastric pH monitoring was done for PD analysis. The PKs and PDs of tegoprazan were compared among the various meal timings. Compared with the fasting condition, the PK profile of tegoprazan was similar when administered 30\u00a0min before a high\u2010fat meal; however, delayed absorption with similar systemic exposure was observed when administered 30\u00a0min after a high\u2010fat meal. The magnitude of acid suppression evaluated through the PD parameters increased when administered 30\u00a0min after a high\u2010fat meal compared with fasting the condition and when administered 30\u00a0min before a high\u2010fat meal. However, the increased difference in acid suppression was not clinically significant. Meal timing had no clinically significant effect on the PKs and PDs of tegoprazan 50\u00a0mg. Therefore, the marketed dosage of tegoprazan could be administered regardless of the meal timing.<\/jats:p><\/jats:sec><jats:sec><jats:label\/><jats:p>\n<jats:boxed-text content-type=\"box\" position=\"anchor\"><jats:caption><jats:title>Study Highlights<\/jats:title><\/jats:caption><jats:p>\n<jats:list list-type=\"simple\">\n\n<jats:list-item><jats:p>\n<jats:bold>WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?<\/jats:bold>\n<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><jats:p>Tegoprazan, a novel potassium\u2010competitive acid blocker, is used to treat acid\u2010related diseases.\n<jats:list list-type=\"simple\">\n<jats:list-item><jats:p><jats:bold>WHAT QUESTION DID THIS STUDY ADDRESS?<\/jats:bold><\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><jats:p>This study evaluated the effect of food on pharmacokinetics (PKs) and pharmacodynamics (PDs) of tegoprazan under various mealtime conditions.\n<jats:list list-type=\"simple\">\n<jats:list-item><jats:p><jats:bold>WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?<\/jats:bold><\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><jats:p>This study showed that delayed absorption of tegoprazan was observed at \u201cafter meal condition,\u201d however, the amount of systemic exposure of \u201cafter meal condition\u201d was similar to \u201cfasting condition\u201d and \u201cbefore meal condition.\u201d In addition, gastric acid suppression of tegoprazan was similar between fasting condition and before meal condition, whereas increased gastric acid suppression was observed at after meal condition.\n<jats:list list-type=\"simple\">\n<jats:list-item><jats:p><jats:bold>HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?<\/jats:bold><\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><jats:p>In the actual clinical environment, patients take medicine under various fed conditions. This study evaluated the effect of food on PKs and PDs of tegoprazan in various clinical conditions, and provided the important information about meal timing when administering tegoprazan.<\/jats:p><\/jats:boxed-text>\n<\/jats:p><\/jats:sec>","DOI":"10.1111\/cts.12958","type":"journal-article","created":{"date-parts":[[2020,12,31]],"date-time":"2020-12-31T22:38:32Z","timestamp":1609454312000},"page":"934-941","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Effect of meal timing on pharmacokinetics and pharmacodynamics of tegoprazan in healthy male volunteers"],"prefix":"10.1111","volume":"14","author":[{"given":"Deok Y.","family":"Yoon","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jung","family":"Sunwoo","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Asan Medical Center University of Ulsan College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naree","family":"Shin","sequence":"additional","affiliation":[{"name":"Division of Clinical Development HK inno.N Corporation Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ah R.","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Clinical Development HK inno.N Corporation Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bongtae","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Clinical Development HK inno.N Corporation Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geun S.","family":"Song","sequence":"additional","affiliation":[{"name":"Division of Clinical Development HK inno.N Corporation Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"In\u2010Jin","family":"Jang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"SeungHwan","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,1,21]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00018-007-7249-x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2017.10.022"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00424-008-0495-4"},{"issue":"1","key":"e_1_2_8_5_1","first-page":"S35","article-title":"Improving on PPI\u2010based therapy of GORD","volume":"13","author":"Sachs G","year":"2001","journal-title":"Eur J Gastroenterol Hepatol"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11894-008-0098-4"},{"issue":"1","key":"e_1_2_8_7_1","first-page":"S29","article-title":"Shortcomings of the first\u2010generation proton pump inhibitors","volume":"13","author":"Tytgat GN","year":"2001","journal-title":"Eur J Gastroenterol Hepatol"},{"key":"e_1_2_8_8_1","first-page":"19","article-title":"When do ulcer patients take their acid inhibiting medication?","volume":"7","author":"Persson K","year":"1993","journal-title":"Hassle Information"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-010-1209-2"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2007.02889.x"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2000.00829.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2006.02911.x"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2009.03979.x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15438"},{"key":"e_1_2_8_15_1","doi-asserted-by":"crossref","unstructured":"HanS ChoiHY KimYH.Pharmacokinetics pharmacodynamics and food\u2010effect of single oral dose of tegoprazan a novel potassium\u2010competitive acid blocker (P\u2010CAB) in healthy male subjects. 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