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Clinical Trial 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.


Clinical Trial Description

Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is single-dose, double-blind, parallel groups, randomized and balanced. Blood samples are collected for up to 90 days, to determine serum drug concentration and anti-drug antibodies. Safety and tolerability are also assessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03919448
Study type Interventional
Source Laboratorios Richmond S.A.C.I.F.
Contact
Status Completed
Phase Phase 1
Start date April 1, 2019
Completion date September 11, 2019

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