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Pharmacokinetic drug interaction and safety after coadministration of clarithromycin, amoxicillin, and ilaprazole: a randomised, open-label, one-way crossover, two parallel sequences study

DC Field Value Language
dc.contributor.author류병원-
dc.contributor.author박민수-
dc.date.accessioned2019-01-17T16:40:24Z-
dc.date.available2019-01-17T16:40:24Z-
dc.date.issued2018-
dc.identifier.issn0031-6970-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/166885-
dc.description.abstractPURPOSE: Ilaprazole, the latest proton pump inhibitor, can be used with clarithromycin and amoxicillin as a triple therapy regimen for eradicating Helicobacter pylori. The aim of this study was to evaluate pharmacokinetic drug interactions and safety profiles after coadministration of clarithromycin, amoxicillin, and ilaprazole. METHODS: A randomised, open-label, one-way crossover, two parallel sequences study was conducted in 32 healthy subjects. In part 1, the subjects received a single dose of ilaprazole 10 mg in period 1 and clarithromycin 500 mg and amoxicillin 1000 mg twice daily for 6 days in period 2. In part 2, the subjects received clarithromycin 500 mg and amoxicillin 1000 mg once in period 1 and ilaprazole 10 mg twice daily for 6 days in period 2. In both sequences, the three drugs were coadministrated once on day 5 in period 2. Pharmacokinetic evaluations of ilaprazole (part 1), and clarithromycin and amoxicillin (part 2) were conducted. RESULTS: Twenty-eight subjects completed the study. For ilaprazole, the peak concentration (Cmax) slightly decreased from 479 (ilaprazole alone) to 446 ng/mL (triple therapy) [Geometric least square mean ratio (90% confidence interval), 0.93 (0.70-1.22)]. The area under the concentration-time curve from 0 h to the last measurable concentration (AUClast) slightly increased from 3301 to 3538 μg·h/mL [1.07 (0.85-1.35)]. For clarithromycin, the Cmax slightly decreased from 1.87 to 1.72 μg/mL [0.90 (0.70-1.15)], and AUClast slightly increased from 14.6 to 16.5 μg·h/mL [1.09 (0.87-1.37)]. For amoxicillin, the Cmax slightly decreased from 9.37 to 8.14 μg/mL [0.86 (0.74-1.01)], and AUClast slightly decreased from 27.9 to 26.7 μg·h/mL [0.98 (0.83-1.16)]. These changes in the PK parameters of each drug were not statistically significant. CONCLUSIONS: The coadministration of ilaprazole, clarithromycin, and amoxicillin was tolerable and did not cause a significant PK drug interaction. Thus, a triple therapy regimen comprising ilaprazole, clarithromycin, and amoxicillin may be an option for the eradication of H. pylori. Clinicaltrials.gov number: NCT02998437.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherSpringer-
dc.relation.isPartOfEUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESH2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage-
dc.subject.MESH2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects-
dc.subject.MESH2-Pyridinylmethylsulfinylbenzimidazoles/blood-
dc.subject.MESH2-Pyridinylmethylsulfinylbenzimidazoles/pharmacokinetics*-
dc.subject.MESHAdult-
dc.subject.MESHAmoxicillin/administration & dosage-
dc.subject.MESHAmoxicillin/adverse effects-
dc.subject.MESHAmoxicillin/blood-
dc.subject.MESHAmoxicillin/pharmacokinetics*-
dc.subject.MESHAnti-Bacterial Agents/administration & dosage-
dc.subject.MESHAnti-Bacterial Agents/adverse effects-
dc.subject.MESHAnti-Bacterial Agents/blood-
dc.subject.MESHAnti-Bacterial Agents/pharmacokinetics*-
dc.subject.MESHClarithromycin/administration & dosage-
dc.subject.MESHClarithromycin/adverse effects-
dc.subject.MESHClarithromycin/blood-
dc.subject.MESHClarithromycin/pharmacokinetics*-
dc.subject.MESHCross-Over Studies-
dc.subject.MESHDrug Interactions-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHHealthy Volunteers-
dc.subject.MESHHelicobacter Infections/drug therapy-
dc.subject.MESHHelicobacter Infections/microbiology-
dc.subject.MESHHelicobacter pylori/drug effects-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPatient Safety-
dc.subject.MESHProton Pump Inhibitors/administration & dosage-
dc.subject.MESHProton Pump Inhibitors/adverse effects-
dc.subject.MESHProton Pump Inhibitors/blood-
dc.subject.MESHProton Pump Inhibitors/pharmacokinetics*-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHRisk Assessment-
dc.subject.MESHYoung Adult-
dc.titlePharmacokinetic drug interaction and safety after coadministration of clarithromycin, amoxicillin, and ilaprazole: a randomised, open-label, one-way crossover, two parallel sequences study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentOthers-
dc.contributor.googleauthorByung Hak Jin-
dc.contributor.googleauthorByung Won Yoo-
dc.contributor.googleauthorJungsin Park-
dc.contributor.googleauthorJung Hye Kim-
dc.contributor.googleauthorJun Yeon Lee-
dc.contributor.googleauthorJae Soo Shin-
dc.contributor.googleauthorMin Soo Park-
dc.identifier.doi10.1007/s00228-018-2489-2-
dc.contributor.localIdA02468-
dc.contributor.localIdA01468-
dc.relation.journalcodeJ00816-
dc.identifier.eissn1432-1041-
dc.identifier.pmid29846770-
dc.identifier.urlhttps://link.springer.com/article/10.1007/s00228-018-2489-2-
dc.subject.keywordAmoxicillin-
dc.subject.keywordClarithromycin-
dc.subject.keywordDrug interaction-
dc.subject.keywordIlaprazole-
dc.subject.keywordPharmacokinetics-
dc.subject.keywordProton pump inhibitor-
dc.contributor.alternativeNameYoo, Byungwon-
dc.contributor.affiliatedAuthor류병원-
dc.contributor.affiliatedAuthor박민수-
dc.citation.volume74-
dc.citation.number9-
dc.citation.startPage1149-
dc.citation.endPage1157-
dc.identifier.bibliographicCitationEUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, Vol.74(9) : 1149-1157, 2018-
dc.identifier.rimsid60327-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers

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