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Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

NCT04873765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

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 pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.

Conditions

Interventions

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

Sponsors & Collaborators

  • Megalabs

    lead INDUSTRY

Principal Investigators

  • José Pedrazzoli Junior, MD · Unidade Integrada de Farmacologia e Gastroenterologia

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
2022-03-18
Primary Completion
2022-08-18
Completion
2022-09-18

Countries

  • Uruguay

Study Locations

More Related Trials

Entities

Diseases

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 NCT04873765 on ClinicalTrials.gov