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Randomized, double-blind, parallel, 2-arm phase 1 study assessing pharmacokinetics (PK) comparability between a newly developed GP2017 citrate-free -HCF and the currently approved GP2017

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Randomized, double-blind, parallel, 2-arm phase 1 study assessing pharmacokinetics (PK) comparability between a newly developed GP2017 citrate-free -HCF and the currently approved GP2017

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Feb 2023

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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 Pharmacokinetics

    • Most Recent Events

    • 30 Jan 2023 According to Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation of adalimumab. The authorization includes all indications covered by the reference medicine: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uvetis.
    • 21 Dec 2022 New trial record
    • 26 Oct 2022 Results presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022

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