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
Sponsor study identifier
Secondary identifiers
OTHER · Alias Study Number
interventional
24
1 country
1
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
March 2016
Actual (reported)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®.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 2016
Actual (reported)March 2016
Actual (reported)May 6, 2016
Actual (reported)May 10, 2016
Actual (reported)Area under the serum filgrastim concentration versus time curve from zero to infinity (AUC0-∞)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Maximum serum filgrastim concentration (Cmax)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Area under the effect curve for Absolute Neutrophil Count (ANC) (AUEC ANC)
1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration
Maximum observed ANC ( ANC max)
1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration
Time to maximum serum filgrastim concentration (Tmax)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Elimination half-life (t ½)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Area under the serum filgrastim concentration versus time curve from time zero to the time of the last measurable concentration versus time curve from time zero to the time of the last measurable concentration (AUC0-t)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Clearance (CL)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Time to maximum ANC (Tmax[ANC])
1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
SeaView Research, Inc
Miami, Florida, 33126, United States
Yao HM, Ottery FD, Borema T, Harris S, Levy J, May TB, Moosavi S, Zhang J, Summers M. PF-06881893 (Nivestym), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(R)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. BioDrugs. 2019 Apr;33(2):207-220. doi: 10.1007/s40259-019-00343-8.
Pfizer CT.Gov Call Center
Pfizer
24 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
May 10, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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