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An assesor blind, balanced, randomized, two-treatment, two period, single-dose, two way crossover, comparative subcutaneous pharmacokinetic and pharmacodynamic study of two dose levels of INTP5 of Intas pharmaceuticals ltd., India Ahmedabad, India with two dose levels of Neulasta of Amgen (EU licensed product) in healthy, normal adult human subjects under fasting condition. - NA

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Trial Profile

An assesor blind, balanced, randomized, two-treatment, two period, single-dose, two way crossover, comparative subcutaneous pharmacokinetic and pharmacodynamic study of two dose levels of INTP5 of Intas pharmaceuticals ltd., India Ahmedabad, India with two dose levels of Neulasta of Amgen (EU licensed product) in healthy, normal adult human subjects under fasting condition. - NA

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Aug 2019

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Intas Pharmaceuticals

    • Most Recent Events

    • 31 Aug 2016 New trial record
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