A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

Abstract Background/objective FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), i...

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Bibliographic Details
Main Authors: Jim Bush, Kazuki Kawakami, Rafael Muniz
Format: Article
Language:English
Published: BMC 2019-12-01
Series:BMC Pharmacology and Toxicology
Subjects:
Adalimumab
Biosimilar
Immunogenicity
Pharmacokinetics
Safety
Online Access:https://doi.org/10.1186/s40360-019-0376-9

Internet

https://doi.org/10.1186/s40360-019-0376-9

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