{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T14:36:05Z","timestamp":1783434965704,"version":"3.54.6"},"reference-count":28,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,7,13]],"date-time":"2023-07-13T00:00:00Z","timestamp":1689206400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Quadruple therapy comprising 2 antibiotics, a proton pump inhibitor, and bismuth, is recommended for <jats:italic>Helicobacter pylori<\/jats:italic> eradication in China. This Phase 1, double\u2010blind, parallel\u2010group study aimed to evaluate the pharmacokinetics, safety, and tolerability of bismuth\u2010containing vonoprazan\u2010 or esomeprazole\u2010based quadruple therapy in <jats:italic>H. pylori<\/jats:italic>\u2013positive healthy subjects at a single site in China. Quadruple therapy comprising vonoprazan 20\u00a0mg or esomeprazole 20\u00a0mg with bismuth potassium citrate 600\u00a0mg (equivalent to bismuth 220\u00a0mg), clarithromycin 500\u00a0mg, and amoxicillin 1000\u00a0mg was administered twice daily for 2\u00a0weeks. Forty\u2010four subjects were enrolled, 22 each in the vonoprazan (mean age, 34.5\u00a0years; men, 63.6%) and esomeprazole (mean age, 31.6\u00a0years; men, 59.1%) groups. Day 14 bismuth plasma pharmacokinetic parameters area under the plasma concentration\u2013time curve during a dosing interval (geometric mean ratio, 1.07 [90% confidence interval, 0.82\u20131.40]) and maximum observed plasma concentration (geometric mean ratio, 1.30 [90% confidence interval, 0.94\u20131.81]) were similar between the treatment groups. At Day 42 follow\u2010up, 100% and 94.4% of subjects were <jats:italic>H. pylori<\/jats:italic> negative in the vonoprazan and esomeprazole groups, respectively. The incidence of treatment\u2010emergent adverse events was similar between the groups, with no serious adverse events. No new safety concerns were identified. In conclusion, vonoprazan had no significant effect on plasma bismuth exposure compared with esomeprazole.<\/jats:p>","DOI":"10.1002\/cpdd.1276","type":"journal-article","created":{"date-parts":[[2023,7,14]],"date-time":"2023-07-14T03:58:40Z","timestamp":1689307120000},"page":"1036-1044","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Pharmacokinetics, Safety, and Tolerability of Vonoprazan\u2010 or Esomeprazole\u2010Based Bismuth\u2010Containing Quadruple Therapy: A Phase 1, Double\u2010Blind, Parallel\u2010Group Study in Adults with <i>Helicobacter pylori<\/i> Infection in China"],"prefix":"10.1002","volume":"12","author":[{"given":"Jia","family":"Miao","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology West China Hospital, Sichuan University  Chengdu China"},{"name":"Clinical Trial Center West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Hu","sequence":"additional","affiliation":[{"name":"Clinical Trial Center West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Tang","sequence":"additional","affiliation":[{"name":"Clinical Trial Center West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenyan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Critical Care Medicine West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Trial Center West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruoting","family":"Men","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liqun","family":"Gu","sequence":"additional","affiliation":[{"name":"Takeda Development Center Asia  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Takeda Development Center Japan  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Czerniak","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  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