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Open Label Randomized Two Treatment Two Sequence Two Period Crossover Single Dose Pharmacokinetic Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Prefilled Syringe With on Body Injector 6mg as Test Product (T) Manufactured by Kashiv Biosiciences LLC, USA With Fylnetra Prefilled Syringe 6mg as Reference Product (R) Manufactured by Kashiv Biosciences LLC, USA Administered Through Subcutaneous Route in Normal Healthy Adult (Males and Females ) Human Subjects Under Fasting Condition

Trial Profile

Open Label Randomized Two Treatment Two Sequence Two Period Crossover Single Dose Pharmacokinetic Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Prefilled Syringe With on Body Injector 6mg as Test Product (T) Manufactured by Kashiv Biosiciences LLC, USA With Fylnetra Prefilled Syringe 6mg as Reference Product (R) Manufactured by Kashiv Biosciences LLC, USA Administered Through Subcutaneous Route in Normal Healthy Adult (Males and Females ) Human Subjects Under Fasting Condition

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2025

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacokinetics
  • Sponsors Kashiv BioSciences

Most Recent Events

  • 17 Apr 2025 New trial record

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