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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®.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2016-03 |
| Completion | 2016-06 |
Conditions
- Neutropenia (Low White Blood Cell Count)
Interventions
- Filgrastim Hospira (US)
- U.S.-approved Neupogen®
Primary outcomes
- The Area under the effect curve for CD34+ (AUECCD34+) — prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
- Maximum observed value for CD34+ (CD34+max) — prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
- Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24) — prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
- Maximum serum filgrastim concentration (Cmax) following study drug administration on Day 5 — prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Countries
United States