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PK/PD of Biosimilar Pegfilgrastim (B12019) vs Neulasta in Healthy Subjects
NCT02629562Phase 1Completed
- Sponsor
- Cinfa Biotech
- Start
- Nov 2015
- Primary completion
- Jul 2016
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of pegfilgrastim in neutropenia (2 arms), sponsored by Cinfa Biotech. Primary endpoints: Area Under the Curve from time zero to last quantifiable concentration at 6 weeks, Maximum Observed Concentration at 6 weeks and 1 more. Started Nov 2015; status: completed.
02
Drugs
pegfilgrastim
03
Conditions
neutropenia
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