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Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials...

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Detalles Bibliográficos
Autores principales: Yu, Kyung‐Sang, Jang, In‐Jin, Lim, Hyeong‐Seok, Hong, Jang Hee, Kim, Min‐Gul, Park, Min Kyu, Cho, Doo‐Yeoun, Park, Min Soo, Chung, Jae Yong, Ghim, Jong‐Lyul, Lee, SeungHwan, Yoon, Seok Kyu, Kwon, In Sun, Lee, Sang Joon, Kim, Sung Hyun, Bae, Yun Ju, Cha, Jung Bin, Furst, Daniel E., Keystone, Edward, Kay, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301575/
https://www.ncbi.nlm.nih.gov/pubmed/33503313
http://dx.doi.org/10.1111/cts.12967