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
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).
Mots clés
Herceptin(®), biosimilars, breast cancer, pharmacokinetic equivalence, trastuzumab
Référence
Clin Ther. 2016 Jul;38(7):1665-1673.e3