Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study
DC Field | Value | Language |
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dc.contributor.author | Park, Won | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Yun, Jihye | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2022-07-15T21:06:36Z | - |
dc.date.available | 2022-07-15T21:06:36Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2015-09 | - |
dc.identifier.issn | 1744-666X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/156429 | - |
dc.description.abstract | Objective: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima (R), Inflectra (R)]) with two formulations of the reference medicinal product (RMP) (Remicade (R)) from either Europe (EU-RMP) or the USA (US-RMP). Methods: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. Results: Baseline demographics were well balanced across the three groups. Primary end points (C-max, AUC(last) and AUC(inf)) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. Conclusion: The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS LTD | - |
dc.title | Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1586/1744666X.2015.1090311 | - |
dc.identifier.scopusid | 2-s2.0-84942237438 | - |
dc.identifier.wosid | 000369964700004 | - |
dc.identifier.bibliographicCitation | EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v.11, no.s1, pp.S25 - S31 | - |
dc.relation.isPartOf | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.citation.title | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.citation.volume | 11 | - |
dc.citation.number | s1 | - |
dc.citation.startPage | S25 | - |
dc.citation.endPage | S31 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | ALPHA MONOCLONAL-ANTIBODY | - |
dc.subject.keywordPlus | ANKYLOSING-SPONDYLITIS | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | INNOVATOR INFLIXIMAB | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | METHOTREXATE | - |
dc.subject.keywordAuthor | biosimilar | - |
dc.subject.keywordAuthor | CT-P13 | - |
dc.subject.keywordAuthor | European Union | - |
dc.subject.keywordAuthor | healthy subjects | - |
dc.subject.keywordAuthor | infliximab | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordAuthor | safety | - |
dc.subject.keywordAuthor | USA | - |
dc.identifier.url | https://www.tandfonline.com/doi/full/10.1586/1744666X.2015.1090311 | - |
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