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About
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®.
Full description
This is a randomized, open-label, multiple-dose, crossover study evaluating the pharmacodynamics and Pharmacokinetics equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit. There will be 30 healthy subjects in each of the two sequences.
After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2 treatment sequences:
Subjects will receive one of each of the drugs once a day for 5 days in each of the treatment sequences.
Enrollment
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Inclusion criteria
A subject will be eligible for study participation if all of the following criteria are met at Screening:
Exclusion criteria
A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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