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Bioequivalence of CHS-1701 (Udenyca) vs Neulasta in Healthy Subjects
NCT02650973Phase 1Completed
- Sponsor
- Coherus BioSciences, Inc.
- Start
- Feb 2016
- Primary completion
- Jun 2016
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, single-blind trial of pegfilgrastim in febrile neutropenia (FN) (3 arms), sponsored by Coherus BioSciences, Inc. Primary endpoints: Bioequivalence as measured by PK and PD at 84 Days, Maximum Absolute Neutrophil Count at 84 Days and 1 more. Started Feb 2016; status: completed.
02
Drugs
pegfilgrastim
03
Conditions
febrile neutropenia (FN)
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