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A randomized, double-blind, two-treatment, single-period, parallel design study to compare the pharmacokinetics and pharmacodynamics (PK/PD) of R-TPR-029 (test pegfilgrastim) 6 mg/0.6 mL of Reliance Life Sciences Pvt. Ltd., India with Neulasta (reference pegfilgrastim) of Amgen Europe BV, the Netherlands in healthy, adult, human subjects following subcutaneous administration under fasting condition.

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Trial Profile

A randomized, double-blind, two-treatment, single-period, parallel design study to compare the pharmacokinetics and pharmacodynamics (PK/PD) of R-TPR-029 (test pegfilgrastim) 6 mg/0.6 mL of Reliance Life Sciences Pvt. Ltd., India with Neulasta (reference pegfilgrastim) of Amgen Europe BV, the Netherlands in healthy, adult, human subjects following subcutaneous administration under fasting condition.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Reliance Life Sciences
  • Most Recent Events

    • 09 Sep 2016 New trial record

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