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A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

NCT03919448 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-07-27

Study results available
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Summary

The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin® (reference product) and Cizumab® (Indian origin), to establish similarity.

Conditions

  • Pharmacokinetics
  • Safety Issues

Interventions

BIOLOGICAL

Bevacizumab

Single-dose infusion

Sponsors & Collaborators

  • FP Clinical Pharma S.R.L.

    collaborator INDUSTRY

  • Syngene

    collaborator INDUSTRY

  • Laboratorios Richmond S.A.C.I.F.

    lead INDUSTRY

Principal Investigators

  • Ethel C Feleder, MD · FP Clinical Pharma S.R.L.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-11
Completion
2019-09-11

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs

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 NCT03919448 on ClinicalTrials.gov