{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T10:07:16Z","timestamp":1753870036009,"version":"3.41.2"},"reference-count":30,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,5,19]],"date-time":"2016-05-19T00:00:00Z","timestamp":1463616000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Proton pump inhibitors (<jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>s) effectively block gastric acid secretion and are the treatment of choice for heartburn. <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>s differ, however, in onset of action and bioavailability. In this single\u2010center, open\u2010label, three\u2010way crossover study, onset of action of immediate\u2010release omeprazole 20\u00a0mg\/sodium bicarbonate 1100\u00a0mg (<jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content>) and delayed\u2010release (<jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>) lansoprazole 15\u00a0mg was evaluated in 63 healthy fasting adults. Subjects were randomized to once daily <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content>, or <jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>\u2010lansoprazole, or no treatment for 7\u00a0days. The primary efficacy endpoint was the earliest time where a statistically significant difference was observed between <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>\u2010lansoprazole in median intragastric <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> scores for three consecutive 5\u2010min intervals on day 7. Secondary endpoints compared effects of active treatments on days 1 and 7 (e.g., time to sustained inhibition, percentage of time with <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> &gt;4). A significant difference in median intragastric <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> favoring <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> was observed on day 7 starting at the 10\u2010 to 15\u2010min interval postdosing (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.024) and sustaining through the 115\u2010 to 120\u2010min interval (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.017). On day 1, <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> achieved sustained inhibition of intragastric acidity significantly faster than <jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>\u2010lansoprazole. <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> maintained <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> &gt;4 significantly longer than <jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>\u2010lansoprazole over a 24\u2010h period (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.007) on day 7. Overall, results of this study demonstrate <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> is safe and well tolerated and that treatment with <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">OME<\/jats:styled-content> results in significantly faster onset of action and better gastric acid suppression at steady state than <jats:styled-content style=\"fixed-case\">DR<\/jats:styled-content>\u2010lansoprazole.<\/jats:p>","DOI":"10.1002\/prp2.238","type":"journal-article","created":{"date-parts":[[2016,5,24]],"date-time":"2016-05-24T05:38:24Z","timestamp":1464068304000},"source":"Crossref","is-referenced-by-count":5,"title":["A randomized, crossover pharmacodynamic study of immediate\u2010release omeprazole\/sodium bicarbonate and delayed\u2010release lansoprazole in healthy adult volunteers"],"prefix":"10.1002","volume":"4","author":[{"given":"Vijayalakshmi S.","family":"Pratha","sequence":"first","affiliation":[{"name":"Clinical Applications Lab., Inc. 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Kenilworth New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Tobin","sequence":"additional","affiliation":[{"name":"International HealthCare, LLC Norwalk Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,5,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2004.02140.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13194"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.4292\/wjgpt.v5.i3.105"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/000200917"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9270(01)02580-1"},{"key":"e_1_2_9_7_1","first-page":"19862","article-title":"Part 331: antacid products for over\u2010the\u2010counter human use: rules and regulations","volume":"39","author":"Food & Drug Administration","year":"1974","journal-title":"Fed Regist"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1159\/000235953"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2000.00829.x"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199120010-00003"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2005.02709.x"},{"key":"e_1_2_9_12_1","first-page":"181","article-title":"pH, healing rate, and symptom relief in patients with GERD","volume":"72","author":"Huang JQ","year":"1999","journal-title":"Yale J Biol Med"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.1995.tb00777.x"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.159.7.649"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2006.03191.x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"crossref","first-page":"S561","DOI":"10.1038\/ajg.2013.270","article-title":"Performance differences between Zegerid\u00ae and PrilosecTM dosage forms: a comparative bioavailability study","volume":"108","author":"Kearbey J","year":"2013","journal-title":"Am J Gastroenterol"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/0140-6736(90)90287-F"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v20.i34.12277"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/2327-6924.12133"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04580.x"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-013-3017-y"},{"key":"e_1_2_9_22_1","first-page":"CD002095","article-title":"Short\u2010term treatment with proton pump inhibitors, H2\u2010receptor antagonists and prokinetics for gastro\u2010oesophageal reflux disease\u2010like symptoms and endoscopy negative reflux disease","volume":"11","author":"Pinxteren B","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1015009300955"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-004-0804-6"},{"issue":"1","key":"e_1_2_9_25_1","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1111\/j.1365-2036.1993.tb00582.x","article-title":"The continuing development of gastric acid pump inhibitors","volume":"7","author":"Sachs G","year":"1993","journal-title":"Aliment Pharmacol Ther"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11894-008-0098-4"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12860"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0116308"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270010377501"},{"key":"e_1_2_9_30_1","unstructured":"Zegerid\u00aeOTC [package insert](2016).Bayer AG Leverkusen Germany. 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