A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects.

Fiche publication

Date publication

juillet 2016

Journal

Clinical therapeutics

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PIVOT Xavier , Dr CURTIT Elsa

Tous les auteurs :
Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, Kim Y, Kim H, Fuhr R

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/27368117

Résumé

This first-in-human study with SB3 was designed to evaluate the pharmacokinetic (PK) equivalence between SB3 and trastuzumab sourced in the European Union (EU trastuzumab), between SB3 and trastuzumab sourced in the United States (US trastuzumab), and between EU and US trastuzumab (NCT02075073).