CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 112 enrolled
Drug / intervention
Bevacizumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03919448
NCT03919448Phase 1Completed
CompareCT.gov

A Double-blind, Randomized, Balanced, Parallel Group, Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

Laboratorios Richmond S.A.C.I.F.·interventional·Posted Apr 18, 2019·Updated Jul 27, 2023

In Brief

A Phase 1 clinical trial evaluating Bevacizumab for Pharmacokinetics and Safety Issues. Completed, enrolled 112 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Safety Issues
CountriesArgentina
CollaboratorsFP Clinical Pharma S.R.L., Syngene

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartApr 1, 2019
Primary CompletionSep 11, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.2 years ago

Interventions

Bevacizumabbiological

Single-dose infusion