drugset / Trial / NCT02479646

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

NCT02479646

Phase 1 Completed 218 enrolled Mylan Inc.
RandomizedCrossoverTriple-blindHealth-services research

Summary

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.

Timeline

Start
2014-09
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject MYL-1401H Unknown 2 mg Subcutaneous

Indications

No indication recorded.