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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Jun 2019

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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).
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