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®.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
SeaView Research, Inc
Miami, Florida, United States
Area under the serum filgrastim concentration versus time curve from zero to infinity (AUC0-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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])
Time frame: 1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration
Volume of distribution (Vd)
Time frame: 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
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