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Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers

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Trial Profile

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 May 2018

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At a glance

  • Drugs Infliximab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics; Registrational
  • Acronyms REFLECTIONS
  • Sponsors Pfizer

    • Most Recent Events

    • 24 May 2018 According to a Sandoz media release, based on data from this trial and from a phase III trial, the European Commission (EC) has approved Zessly (infliximab) biosimilar for its use in Europe.
    • 23 Mar 2018 According to a 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 of infliximab.
    • 31 May 2017 According to a Sandoz media release, the European Medicines Agency (EMA) has accepted for regulatory review the Marketing Authorization Application (MAA) for infliximab biosimilar (Remicade). The submission included data from this trial and another phase III trial.

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