Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects
This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/c...
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| Veröffentlicht in: | Journal of clinical pharmacology 2021-07, Vol.61 (7), p.913-922 |
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| creator | Ghim, Jong‐Lyul Chin, May Chien Jung, Jinah Lee, Jiwon Kim, Seokuee Kim, Bongtae Song, Geun Seog Choi, Young‐Kyung Shin, Jae‐Gook |
| description | This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14‐hydroxyclarithromycin (14‐OH‐clarithromycin). Cohort 2 was an open‐label, randomized, active‐controlled, parallel multiple‐dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole‐based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased Css,max (2.2‐fold) and AUCτ (2.7‐fold) of tegoprazan and M1 (2.1‐ and 2.2‐fold for Css,max and AUCτ, respectively) compared with administration of tegoprazan alone. The Css,max and AUCτ of 14‐OH‐clarithromycin increased by 1.7‐ and 1.8‐fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan‐based therapies (both 50‐ and 100‐mg therapies) maintained pH above 6 for more than 88% of the 24‐hour period, which was significantly longer compared with pantoprazole‐based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated in healthy subjects. In conclusion, the exposure of tegoprazan was increased after coadministration of amoxicillin/clarithromycin, which led to increase pharmacodynamic response measured by intragastric pH compared with tegoprazan alone. Therefore, tegoprazan‐based triple therapy would be effective therapeutic regimen to manage intragastric pH in terms of gastric or duodenal ulcers healing, treatment of gastroesophageal reflux disease, and Helicobacter pylori eradication. |
| doi_str_mv | 10.1002/jcph.1805 |
| format | Article |
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Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14‐hydroxyclarithromycin (14‐OH‐clarithromycin). Cohort 2 was an open‐label, randomized, active‐controlled, parallel multiple‐dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole‐based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased Css,max (2.2‐fold) and AUCτ (2.7‐fold) of tegoprazan and M1 (2.1‐ and 2.2‐fold for Css,max and AUCτ, respectively) compared with administration of tegoprazan alone. The Css,max and AUCτ of 14‐OH‐clarithromycin increased by 1.7‐ and 1.8‐fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan‐based therapies (both 50‐ and 100‐mg therapies) maintained pH above 6 for more than 88% of the 24‐hour period, which was significantly longer compared with pantoprazole‐based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated in healthy subjects. In conclusion, the exposure of tegoprazan was increased after coadministration of amoxicillin/clarithromycin, which led to increase pharmacodynamic response measured by intragastric pH compared with tegoprazan alone. Therefore, tegoprazan‐based triple therapy would be effective therapeutic regimen to manage intragastric pH in terms of gastric or duodenal ulcers healing, treatment of gastroesophageal reflux disease, and Helicobacter pylori eradication.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1002/jcph.1805</identifier><identifier>PMID: 33341955</identifier><language>eng</language><publisher>HOBOKEN: Wiley</publisher><subject><![CDATA[Adult ; Amoxicillin ; Amoxicillin - administration & dosage ; Amoxicillin - pharmacokinetics ; Amoxicillin - pharmacology ; Antibiotics ; Area Under Curve ; Benzene Derivatives - administration & dosage ; Benzene Derivatives - pharmacokinetics ; Benzene Derivatives - pharmacology ; Clarithromycin ; Clarithromycin - administration & dosage ; Clarithromycin - analogs & derivatives ; Clarithromycin - metabolism ; Clarithromycin - pharmacokinetics ; Clarithromycin - pharmacology ; Dose-Response Relationship, Drug ; Drug Combinations ; drug interaction ; Gastroesophageal reflux ; Gastrointestinal Agents - administration & dosage ; Gastrointestinal Agents - pharmacokinetics ; Gastrointestinal Agents - pharmacology ; Healthy Volunteers ; Humans ; Hydrogen-Ion Concentration ; Imidazoles - administration & dosage ; Imidazoles - pharmacokinetics ; Imidazoles - pharmacology ; Life Sciences & Biomedicine ; Male ; Metabolic Clearance Rate ; Middle Aged ; Penicillin ; pH effects ; Pharmacodynamics ; Pharmacokinetics ; Pharmacology & Pharmacy ; Science & Technology ; tegoprazan ; Ulcers]]></subject><ispartof>Journal of clinical pharmacology, 2021-07, Vol.61 (7), p.913-922</ispartof><rights>2020, The American College of Clinical Pharmacology</rights><rights>2020, The American College of Clinical Pharmacology.</rights><rights>2021, The American College of Clinical Pharmacology</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>13</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000606967400001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c3535-4413d00988d6c73c9563635556919c514c9f14baa6e3832bb6920d7d712b89fa3</citedby><cites>FETCH-LOGICAL-c3535-4413d00988d6c73c9563635556919c514c9f14baa6e3832bb6920d7d712b89fa3</cites><orcidid>0000-0002-6137-786X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjcph.1805$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjcph.1805$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,39263,45579,45580</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33341955$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ghim, Jong‐Lyul</creatorcontrib><creatorcontrib>Chin, May Chien</creatorcontrib><creatorcontrib>Jung, Jinah</creatorcontrib><creatorcontrib>Lee, Jiwon</creatorcontrib><creatorcontrib>Kim, Seokuee</creatorcontrib><creatorcontrib>Kim, Bongtae</creatorcontrib><creatorcontrib>Song, Geun Seog</creatorcontrib><creatorcontrib>Choi, Young‐Kyung</creatorcontrib><creatorcontrib>Shin, Jae‐Gook</creatorcontrib><title>Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects</title><title>Journal of clinical pharmacology</title><addtitle>J CLIN PHARMACOL</addtitle><addtitle>J Clin Pharmacol</addtitle><description>This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14‐hydroxyclarithromycin (14‐OH‐clarithromycin). Cohort 2 was an open‐label, randomized, active‐controlled, parallel multiple‐dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole‐based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased Css,max (2.2‐fold) and AUCτ (2.7‐fold) of tegoprazan and M1 (2.1‐ and 2.2‐fold for Css,max and AUCτ, respectively) compared with administration of tegoprazan alone. The Css,max and AUCτ of 14‐OH‐clarithromycin increased by 1.7‐ and 1.8‐fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan‐based therapies (both 50‐ and 100‐mg therapies) maintained pH above 6 for more than 88% of the 24‐hour period, which was significantly longer compared with pantoprazole‐based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated in healthy subjects. In conclusion, the exposure of tegoprazan was increased after coadministration of amoxicillin/clarithromycin, which led to increase pharmacodynamic response measured by intragastric pH compared with tegoprazan alone. Therefore, tegoprazan‐based triple therapy would be effective therapeutic regimen to manage intragastric pH in terms of gastric or duodenal ulcers healing, treatment of gastroesophageal reflux disease, and Helicobacter pylori eradication.</description><subject>Adult</subject><subject>Amoxicillin</subject><subject>Amoxicillin - administration & dosage</subject><subject>Amoxicillin - pharmacokinetics</subject><subject>Amoxicillin - pharmacology</subject><subject>Antibiotics</subject><subject>Area Under Curve</subject><subject>Benzene Derivatives - administration & dosage</subject><subject>Benzene Derivatives - pharmacokinetics</subject><subject>Benzene Derivatives - pharmacology</subject><subject>Clarithromycin</subject><subject>Clarithromycin - administration & dosage</subject><subject>Clarithromycin - analogs & derivatives</subject><subject>Clarithromycin - metabolism</subject><subject>Clarithromycin - pharmacokinetics</subject><subject>Clarithromycin - pharmacology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Combinations</subject><subject>drug interaction</subject><subject>Gastroesophageal reflux</subject><subject>Gastrointestinal Agents - administration & dosage</subject><subject>Gastrointestinal Agents - pharmacokinetics</subject><subject>Gastrointestinal Agents - pharmacology</subject><subject>Healthy Volunteers</subject><subject>Humans</subject><subject>Hydrogen-Ion Concentration</subject><subject>Imidazoles - administration & dosage</subject><subject>Imidazoles - pharmacokinetics</subject><subject>Imidazoles - pharmacology</subject><subject>Life Sciences & Biomedicine</subject><subject>Male</subject><subject>Metabolic Clearance Rate</subject><subject>Middle Aged</subject><subject>Penicillin</subject><subject>pH effects</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Pharmacology & Pharmacy</subject><subject>Science & Technology</subject><subject>tegoprazan</subject><subject>Ulcers</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>EIF</sourceid><recordid>eNqNkF-L1DAUxYMo7jj64BeQgk8i3b1p_rR5XMrqKAsuuOJjSZPUydgmY5Ki3U9vZmd23wQhkHD4nXNvDkKvMZxjgOpip_bbc9wAe4JWmLGqpBzoU7QCELisaoAz9CLGHQDmlOHn6IwQQrFgbIXubrYyTFL5n9aZZFUspNPFg6gXJ6eD6Ifi1vzw-yDvpCtaL_VknY3JBKOL7zZti8vJ_7HKjqN19xHtKEPWg58WlaV8NkaOabsUX-d-Z1SKL9GzQY7RvDrda_Ttw9Vtuymvv3z81F5el4owwkpKMdH5J02juaqJEowTThhjXGChGKZKDJj2UnJDGlL1PRcV6FrXuOobMUiyRm-Pufvgf80mpm7n5-DyyK5itKIci2xco3dHSgUfYzBDtw92kmHpMHSHlrtDy92h5cy-OSXO_WT0I_lQawaaI_Db9H6IyhqnzCMGABy44DXNL8CtTTJZ71o_u5St7__fmumLE21Hs_x75e5ze7O53_0vzDmobg</recordid><startdate>202107</startdate><enddate>202107</enddate><creator>Ghim, Jong‐Lyul</creator><creator>Chin, May Chien</creator><creator>Jung, Jinah</creator><creator>Lee, Jiwon</creator><creator>Kim, Seokuee</creator><creator>Kim, Bongtae</creator><creator>Song, Geun Seog</creator><creator>Choi, Young‐Kyung</creator><creator>Shin, Jae‐Gook</creator><general>Wiley</general><general>Wiley Subscription Services, Inc</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><orcidid>https://orcid.org/0000-0002-6137-786X</orcidid></search><sort><creationdate>202107</creationdate><title>Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects</title><author>Ghim, Jong‐Lyul ; Chin, May Chien ; Jung, Jinah ; Lee, Jiwon ; Kim, Seokuee ; Kim, Bongtae ; Song, Geun Seog ; Choi, Young‐Kyung ; Shin, Jae‐Gook</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3535-4413d00988d6c73c9563635556919c514c9f14baa6e3832bb6920d7d712b89fa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Amoxicillin</topic><topic>Amoxicillin - administration & dosage</topic><topic>Amoxicillin - pharmacokinetics</topic><topic>Amoxicillin - pharmacology</topic><topic>Antibiotics</topic><topic>Area Under Curve</topic><topic>Benzene Derivatives - administration & dosage</topic><topic>Benzene Derivatives - pharmacokinetics</topic><topic>Benzene Derivatives - pharmacology</topic><topic>Clarithromycin</topic><topic>Clarithromycin - administration & dosage</topic><topic>Clarithromycin - analogs & derivatives</topic><topic>Clarithromycin - metabolism</topic><topic>Clarithromycin - pharmacokinetics</topic><topic>Clarithromycin - pharmacology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Combinations</topic><topic>drug interaction</topic><topic>Gastroesophageal reflux</topic><topic>Gastrointestinal Agents - administration & dosage</topic><topic>Gastrointestinal Agents - pharmacokinetics</topic><topic>Gastrointestinal Agents - pharmacology</topic><topic>Healthy Volunteers</topic><topic>Humans</topic><topic>Hydrogen-Ion Concentration</topic><topic>Imidazoles - administration & dosage</topic><topic>Imidazoles - pharmacokinetics</topic><topic>Imidazoles - pharmacology</topic><topic>Life Sciences & Biomedicine</topic><topic>Male</topic><topic>Metabolic Clearance Rate</topic><topic>Middle Aged</topic><topic>Penicillin</topic><topic>pH effects</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>Pharmacology & Pharmacy</topic><topic>Science & Technology</topic><topic>tegoprazan</topic><topic>Ulcers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ghim, Jong‐Lyul</creatorcontrib><creatorcontrib>Chin, May Chien</creatorcontrib><creatorcontrib>Jung, Jinah</creatorcontrib><creatorcontrib>Lee, Jiwon</creatorcontrib><creatorcontrib>Kim, Seokuee</creatorcontrib><creatorcontrib>Kim, Bongtae</creatorcontrib><creatorcontrib>Song, Geun Seog</creatorcontrib><creatorcontrib>Choi, Young‐Kyung</creatorcontrib><creatorcontrib>Shin, Jae‐Gook</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ghim, Jong‐Lyul</au><au>Chin, May Chien</au><au>Jung, Jinah</au><au>Lee, Jiwon</au><au>Kim, Seokuee</au><au>Kim, Bongtae</au><au>Song, Geun Seog</au><au>Choi, Young‐Kyung</au><au>Shin, Jae‐Gook</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects</atitle><jtitle>Journal of clinical pharmacology</jtitle><stitle>J CLIN PHARMACOL</stitle><addtitle>J Clin Pharmacol</addtitle><date>2021-07</date><risdate>2021</risdate><volume>61</volume><issue>7</issue><spage>913</spage><epage>922</epage><pages>913-922</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14‐hydroxyclarithromycin (14‐OH‐clarithromycin). Cohort 2 was an open‐label, randomized, active‐controlled, parallel multiple‐dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole‐based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased Css,max (2.2‐fold) and AUCτ (2.7‐fold) of tegoprazan and M1 (2.1‐ and 2.2‐fold for Css,max and AUCτ, respectively) compared with administration of tegoprazan alone. The Css,max and AUCτ of 14‐OH‐clarithromycin increased by 1.7‐ and 1.8‐fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan‐based therapies (both 50‐ and 100‐mg therapies) maintained pH above 6 for more than 88% of the 24‐hour period, which was significantly longer compared with pantoprazole‐based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated in healthy subjects. In conclusion, the exposure of tegoprazan was increased after coadministration of amoxicillin/clarithromycin, which led to increase pharmacodynamic response measured by intragastric pH compared with tegoprazan alone. Therefore, tegoprazan‐based triple therapy would be effective therapeutic regimen to manage intragastric pH in terms of gastric or duodenal ulcers healing, treatment of gastroesophageal reflux disease, and Helicobacter pylori eradication.</abstract><cop>HOBOKEN</cop><pub>Wiley</pub><pmid>33341955</pmid><doi>10.1002/jcph.1805</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-6137-786X</orcidid></addata></record> |
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| subjects | Adult Amoxicillin Amoxicillin - administration & dosage Amoxicillin - pharmacokinetics Amoxicillin - pharmacology Antibiotics Area Under Curve Benzene Derivatives - administration & dosage Benzene Derivatives - pharmacokinetics Benzene Derivatives - pharmacology Clarithromycin Clarithromycin - administration & dosage Clarithromycin - analogs & derivatives Clarithromycin - metabolism Clarithromycin - pharmacokinetics Clarithromycin - pharmacology Dose-Response Relationship, Drug Drug Combinations drug interaction Gastroesophageal reflux Gastrointestinal Agents - administration & dosage Gastrointestinal Agents - pharmacokinetics Gastrointestinal Agents - pharmacology Healthy Volunteers Humans Hydrogen-Ion Concentration Imidazoles - administration & dosage Imidazoles - pharmacokinetics Imidazoles - pharmacology Life Sciences & Biomedicine Male Metabolic Clearance Rate Middle Aged Penicillin pH effects Pharmacodynamics Pharmacokinetics Pharmacology & Pharmacy Science & Technology tegoprazan Ulcers |
| title | Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects |
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