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
Price :
$35
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At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Neutropenia
- Focus Pharmacodynamics
- Sponsors Intas Pharmaceuticals
- 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