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.

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.

Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Sep 2016

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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