NCT02766647

A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

A Randomized Open-Label, Single-Dose, Crossover Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Filgrastim Hospira Compared To U.S.-Approved Neupogen® (Amgen) Following Subcutaneous Administration To Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as neutrophils. This type of white cell is important in fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by increasing the number of neutrophils that are produced in the body. This is important for patients who have low neutrophils due to chemotherapy, other treatments such as bone marrow transplant or certain other conditions with symptoms/problems related to low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in the body compared to Neupogen®.

Detailed description

This is a randomized, open-label, single-dose, two-way crossover study evaluating the PK and PD equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit. After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2 treatment sequences: * Filgrastim Hospira (US) followed by US-approved Neupogen® * US-approved Neupogen® followed by Filgrastim Hospira (US) Subjects will receive one of the drugs in the first Period and the other drug in the other Period.

Conditions

• Neutropenia (Low White Blood Cell Count)

Interventions

Type	Name	Description
BIOLOGICAL	Filgrastim Hospira (US)	5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
BIOLOGICAL	US-approved Neupogen®	5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2016-05-10
• Last updated: 2016-05-10

Locations

1 site across 1 country: United States