Cited 9 times in
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 |
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dc.contributor.author | 류병원 | - |
dc.contributor.author | 박민수 | - |
dc.date.accessioned | 2019-01-17T16:40:24Z | - |
dc.date.available | 2019-01-17T16:40:24Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0031-6970 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/166885 | - |
dc.description.abstract | PURPOSE: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Springer | - |
dc.relation.isPartOf | EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | 2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage | - |
dc.subject.MESH | 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects | - |
dc.subject.MESH | 2-Pyridinylmethylsulfinylbenzimidazoles/blood | - |
dc.subject.MESH | 2-Pyridinylmethylsulfinylbenzimidazoles/pharmacokinetics* | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Amoxicillin/administration & dosage | - |
dc.subject.MESH | Amoxicillin/adverse effects | - |
dc.subject.MESH | Amoxicillin/blood | - |
dc.subject.MESH | Amoxicillin/pharmacokinetics* | - |
dc.subject.MESH | Anti-Bacterial Agents/administration & dosage | - |
dc.subject.MESH | Anti-Bacterial Agents/adverse effects | - |
dc.subject.MESH | Anti-Bacterial Agents/blood | - |
dc.subject.MESH | Anti-Bacterial Agents/pharmacokinetics* | - |
dc.subject.MESH | Clarithromycin/administration & dosage | - |
dc.subject.MESH | Clarithromycin/adverse effects | - |
dc.subject.MESH | Clarithromycin/blood | - |
dc.subject.MESH | Clarithromycin/pharmacokinetics* | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Drug Interactions | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Helicobacter Infections/drug therapy | - |
dc.subject.MESH | Helicobacter Infections/microbiology | - |
dc.subject.MESH | Helicobacter pylori/drug effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Patient Safety | - |
dc.subject.MESH | Proton Pump Inhibitors/administration & dosage | - |
dc.subject.MESH | Proton Pump Inhibitors/adverse effects | - |
dc.subject.MESH | Proton Pump Inhibitors/blood | - |
dc.subject.MESH | Proton Pump Inhibitors/pharmacokinetics* | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Risk Assessment | - |
dc.subject.MESH | Young Adult | - |
dc.title | Pharmacokinetic drug interaction and safety after coadministration of clarithromycin, amoxicillin, and ilaprazole: a randomised, open-label, one-way crossover, two parallel sequences study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Others | - |
dc.contributor.googleauthor | Byung Hak Jin | - |
dc.contributor.googleauthor | Byung Won Yoo | - |
dc.contributor.googleauthor | Jungsin Park | - |
dc.contributor.googleauthor | Jung Hye Kim | - |
dc.contributor.googleauthor | Jun Yeon Lee | - |
dc.contributor.googleauthor | Jae Soo Shin | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.identifier.doi | 10.1007/s00228-018-2489-2 | - |
dc.contributor.localId | A02468 | - |
dc.contributor.localId | A01468 | - |
dc.relation.journalcode | J00816 | - |
dc.identifier.eissn | 1432-1041 | - |
dc.identifier.pmid | 29846770 | - |
dc.identifier.url | https://link.springer.com/article/10.1007/s00228-018-2489-2 | - |
dc.subject.keyword | Amoxicillin | - |
dc.subject.keyword | Clarithromycin | - |
dc.subject.keyword | Drug interaction | - |
dc.subject.keyword | Ilaprazole | - |
dc.subject.keyword | Pharmacokinetics | - |
dc.subject.keyword | Proton pump inhibitor | - |
dc.contributor.alternativeName | Yoo, Byungwon | - |
dc.contributor.affiliatedAuthor | 류병원 | - |
dc.contributor.affiliatedAuthor | 박민수 | - |
dc.citation.volume | 74 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1149 | - |
dc.citation.endPage | 1157 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, Vol.74(9) : 1149-1157, 2018 | - |
dc.identifier.rimsid | 60327 | - |
dc.type.rims | ART | - |
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