Trials / Completed
CompletedNCT04873765
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- 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 pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pegfilgastrim Megalabs | Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose |
| BIOLOGICAL | Pegfilgastim Amgen | Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose |
Timeline
- Start date
- 2022-03-18
- Primary completion
- 2022-08-18
- Completion
- 2022-09-18
- First posted
- 2021-05-05
- Last updated
- 2024-08-16
Locations
1 site across 1 country: Uruguay
Source: ClinicalTrials.gov record NCT04873765. Inclusion in this directory is not an endorsement.