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drugset / Trial / NCT04873765

Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

NCT04873765 ↗

Phase 1 Completed 72 enrolled Megalabs
RandomizedCrossoverOpen-labelTreatment

Summary

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.

Timeline

Start
2022-03-18
Primary completion
2022-08-18
Completion
2022-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

neutropenia