Neutropenia (Low White Blood Cell Count) Clinical Trial
Official title:
A Randomized Open-label, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous Administration To Healthy Volunteers
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, 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:
- Filgrastim Hospira (US) in Period 1 followed by US-approved Neupogen® in Period 2.
- US-approved Neupogen® in Period 1 followed by Filgrastim Hospira (US) in Period 2.
Subjects will receive one of each of the drugs once a day for 5 days in each of the
treatment sequences.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science