drugset / Trial / NCT04958772
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.
Timeline
- Start
- 2024-11-01
- Primary completion
- 2025-04-30
- Completion
- 2025-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
Indications
No indication recorded.