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A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects

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Trial Profile

A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Jul 2019

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At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Colorectal cancer
  • Focus Pharmacokinetics
  • Sponsors Celltrion
  • Most Recent Events

    • 09 Mar 2019 Primary endpoint (Pharmacokinetics: maximum serum concentration (Cmax)) has been met, according to the results published in the BioDrugs
    • 09 Mar 2019 Primary endpoint (Pharmacokinetics: AUC from time zero to the last quantifiable concentration (AUClast)) has been met, according to the results published in the BioDrugs
    • 09 Mar 2019 Primary endpoint (Pharmacokinetics: Area under the concentration-time curve from time zero to infinity) has been met, according to the results published in the BioDrugs
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