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Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects

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Trial Profile

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2020

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Acronyms REFLECTIONS B538-01
  • Sponsors Pfizer

    • Most Recent Events

    • 14 Apr 2020 Results (n=133; over up to 10 weeks) of adalimumab concentrations and immunogenicity response analysis determining a model based framework for better understanding of how PK similarity can be optimally designed and interpreting the outcome of PK were published in the British Journal of Clinical Pharmacology
    • 13 Feb 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 18 Nov 2013 Planned End Date changed from 1 Feb 2014 to 1 Dec 2013 as reported by ClinicalTrials.gov.

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