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An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg

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Trial Profile

An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Asthma
  • Focus Pharmacokinetics
  • Sponsors GENERIUM Pharmaceuticals

    • Most Recent Events

    • 28 Oct 2020 New trial record

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