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Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers

NCT04958772 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-16

No results posted yet for this study

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

  • Healthy

Interventions

BIOLOGICAL

Filgrastim Megalabs

Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose

BIOLOGICAL

Granulokine

Granulokine 5 μg/Kg/day, subcutaneous single dose

Sponsors & Collaborators

  • Megalabs

    lead INDUSTRY

Principal Investigators

  • Satish Kumar, MD · Azidus Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-30
Completion
2025-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958772 on ClinicalTrials.gov