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PK/PD Study of MYL-1401H vs Neulasta in Healthy Volunteers
NCT02479646Phase 1Completed
- Sponsor
- Mylan
- Start
- Sep 2014
- Primary completion
- Jun 2015
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of pegfilgrastim in neutropenia (6 arms), sponsored by Mylan. Primary endpoints: Area under the curve above baseline of ANC at Day 29, Maximum change from baseline in absolute neutrophil count at Day 29 and 2 more. Started Sep 2014; status: completed.
02
Drugs
pegfilgrastim
03
Conditions
neutropenia
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