NCT00938678

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

A Phase I, Randomized, Single Dose, Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Pegfilgrastim Hospira Compared to Neulasta (Amgen) Following Subcutaneous Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pegfilgrastim Hospira	Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
DRUG	Neulasta (Amgen)	Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-07-14
• Last updated: 2017-03-20

Locations

1 site across 1 country: United Kingdom