{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T14:36:02Z","timestamp":1783434962240,"version":"3.54.6"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,6,26]],"date-time":"2021-06-26T00:00:00Z","timestamp":1624665600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p><jats:italic>Helicobacter pylori<\/jats:italic> (Hp) eradication plays a key role in the treatment and prevention of peptic ulcer diseases. Increasing clarithromycin resistance in Hp necessitates more effective treatments for eradication, such as bismuth\u2010containing quadruple therapy. We aimed to compare the safety and pharmacokinetics (PK) of bismuth between vonoprazan\u2010 and lansoprazole\u2010containing quadruple therapy in Hp\u2010positive subjects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this randomised, double\u2010blind, parallel\u2010group study, Hp\u2010positive subjects were randomised to receive vonoprazan\u2010 or lansoprazole\u2010containing quadruple therapy. Each subject received vonoprazan 20\u2009mg or lansoprazole 30\u2009mg combined with bismuth 220\u2009mg, clarithromycin 500\u2009mg and amoxicillin 1000\u2009mg twice daily for 14\u2009days. Blood sampling and urine collection for bismuth PK were conducted predose and up to 12\u2009hours postdose at steady\u2010state. The PK parameters of bismuth were derived using a noncompartmental method and compared between treatments. An exploratory breath test for Hp was conducted at screening and at the follow\u2010up visit on day 42. Safety was assessed by adverse event monitoring, physical examinations, vital signs, 12\u2010lead electrocardiograms and clinical laboratory tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 30 subjects were randomised and 26 subjects completed the study (12 in the vonoprazan group and 14 in the lansoprazole group). The systemic exposure of bismuth in the 2 treatments was comparable (~5% difference). All subjects turned negative for Hp at the follow\u2010up visit. No significant difference in safety profiles was noted between the 2 treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The systemic exposure of bismuth was similar between vonoprazan\u2010 and lansoprazole\u2010containing quadruple therapy. Vonoprazan\u2010containing quadruple therapy was safe and well tolerated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14934","type":"journal-article","created":{"date-parts":[[2021,6,3]],"date-time":"2021-06-03T10:31:38Z","timestamp":1622716298000},"page":"138-144","source":"Crossref","is-referenced-by-count":42,"title":["Evaluation of safety and pharmacokinetics of bismuth\u2010containing quadruple therapy with either vonoprazan or lansoprazole for <i>Helicobacter pylori<\/i> eradication"],"prefix":"10.1111","volume":"88","author":[{"given":"Ki Young","family":"Huh","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyewon","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Toxicology Korea University Guro Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu Kyong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Chungbuk National University Hospital  Chungcheongbuk\u2010do Republic of 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 Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals International Co.  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