Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta) in Healthy Volunteers

Trial Profile

Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta) in Healthy Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Oct 2016

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Autoimmune disorders; Cancer
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Mylan
  • Most Recent Events

    • 11 Oct 2016 Primary endpoint (Maximum Serum Concentration (Cmax) of pegfilgrastim) has been met.
    • 11 Oct 2016 Primary endpoint (Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim) has been met.
    • 11 Oct 2016 Primary endpoint (Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax) has been met.
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