A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

Sponsor
Laboratorios Richmond S.A.C.I.F.
Study ID
NCT03919448
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics
  • Safety Issues

Eligibility Criteria

Sex
MALE
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 18, 2019
Start date
Apr 1, 2019
Status verified
Aug 2022
Primary completion
Sep 11, 2019
Completion
Sep 11, 2019

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Zutrab® (Bevacizumab Richmond)
    a single 1 mg/kg IV dose of Bevacizumab
  • Active Comparator: Avastin®
    a single 1 mg/kg IV dose of Bevacizumab
  • Active Comparator: Cizumab®
    a single 1 mg/kg IV dose of Bevacizumab

Primary Outcome Measure

Peak Serum Concentration of Bevacizumab (Cmax) [ Time Frame: 0, 0.33, 0.5, 1, 1.5 hours during infusion, 0.33, 0.66, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512 hours post-infusion ]

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