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Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects

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Trial Profile

Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Nov 2018

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Spondylarthritis; Ulcerative colitis; Uveitis
  • Focus Adverse reactions; Pharmacokinetics; Registrational

    • Most Recent Events

    • 31 Oct 2018 According to a Sandoz media release, the study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters.
    • 31 Oct 2018 According to a Sandoz media release, the US FDA has approved biosimilar, Hyrimoz (adalimumab-adaz) for all indications of reference medicine not protected by orphan exclusivity in US.The The FDA approval of Hyrimoz was based on a comprehensive data package comprising analytical, preclinical and clinical research which also included data from this biosimilarity study and other phase III trial (ADACCESS).
    • 27 Jul 2018 According to a Sandoz media release, the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (adalimumab) for use in rheumatoid arthritis, plaque psoriasis, Crohns disease, uveitis and ulcerative colitis. The approval was based this and other trial (see profile 240006).
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