Trial Profile

An Assessor-blind, Balanced, Parallel, Randomized, Two-treatment, Comparative Immunogenicity Study of Multiple Doses of INTP5 of Intas Pharmaceuticals Limited, India Against Neulasta of Amgen Inc. USA Administered Subcutaneously in Healthy, Adult, Human Subjects Under Fed Condition

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

24 Nov 2020 Results evaluating single dose pharmacokinetics, pharmacodynamics and immunogenicity, and multiple dose immunogenicity of INTP5 (Pegfilgrastim Biosimilar) versus reference Pegfilgrastim published in the Clinical Drug Investigation
09 Jul 2019 Status changed from not yet recruiting to completed.
25 Jun 2018 New trial record

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