Trial Profile
An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 04 Nov 2021
Price :
$35
*
At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Neutropenia
- Focus Pharmacodynamics; Pharmacokinetics
- 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
- 25 Jun 2018 New trial record