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
- Authors
- Park, Won; Lee, Sang Joon; Yun, Jihye; Yoo, Dae Hyun
- Issue Date
- Sep-2015
- Publisher
- TAYLOR & FRANCIS LTD
- Keywords
- biosimilar; CT-P13; European Union; healthy subjects; infliximab; pharmacokinetics; safety; USA
- Citation
- EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v.11, no.s1, pp.S25 - S31
- Indexed
- SCIE
SCOPUS
- Journal Title
- EXPERT REVIEW OF CLINICAL IMMUNOLOGY
- Volume
- 11
- Number
- s1
- Start Page
- S25
- End Page
- S31
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/156429
- DOI
- 10.1586/1744666X.2015.1090311
- ISSN
- 1744-666X
- 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.
- Files in This Item
-
Go to Link
- Appears in
Collections - 서울 의과대학 > 서울 내과학교실 > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/156429)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.