drugset / Trial / NCT00938678

Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers

NCT00938678

Phase 1 Completed 71 enrolled Pfizer
RandomizedCrossoverOpen-labelOther

Summary

This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim Hospira and Neulasta® following a single dose of 6 mg of each product administered subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.

Timeline

Start
2009-06
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

No indication recorded.