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A two-period study to determine pharmacokinetic, pharmacodynamic, bioequivalence and safety of pegfilgrastim-cbqv administered via on-body injector vs prefilled syringe in healthy adult male participants

Trial Profile

A two-period study to determine pharmacokinetic, pharmacodynamic, bioequivalence and safety of pegfilgrastim-cbqv administered via on-body injector vs prefilled syringe in healthy adult male participants

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Jul 2022

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Febrile neutropenia; Neutropenia
  • Focus Pharmacokinetics

Most Recent Events

  • 21 Jul 2022 New trial record
  • 07 Jun 2022 Primary endpoint has been met (Primary endpoints (PK) area under the concentration-time curve from time 0 to infinity (AUC0-inf), the AUC from time 0 to the last quantifiable concentration (AUC0-last), and the maximum plasma concentration (Cmax)) , according to Results presented at the 58th Annual Meeting of the American Society of Clinical Oncology
  • 07 Jun 2022 Results presented at the 58th Annual Meeting of the American Society of Clinical Oncology

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