A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel and US Sourced Enbrel) in Healthy Male Subjects

Trial Profile

A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel and US Sourced Enbrel) in Healthy Male Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 18 May 2017

At a glance

  • Drugs Etanercept (Primary)
  • Indications Asthma; Graft-versus-host disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 12 Sep 2016 According to Merck media release, BRENZYS (etanercept) received approval in Canada for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis.
    • 11 Mar 2016 Results published in the British Journal of Clinical Pharmacology
    • 16 Jan 2016 According to a Biogen media release, etanercept (Benepali) has been approved by the European Commission for marketing in European Union based on results from this and a phase III trial (CTP 700233290).
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top