Trials / Not Yet Recruiting
Not Yet RecruitingNCT04958772
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers
Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Megalabs · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Filgrastim Megalabs | Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose |
| BIOLOGICAL | Granulokine | Granulokine 5 μg/Kg/day, subcutaneous single dose |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2025-04-30
- Completion
- 2025-05-31
- First posted
- 2021-07-12
- Last updated
- 2024-08-16
Source: ClinicalTrials.gov record NCT04958772. Inclusion in this directory is not an endorsement.