drugset / Trial / NCT03919448
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
Phase 1
Completed
112 enrolled
Laboratorios Richmond S.A.C.I.F.
FP Clinical Pharma S.R.L. · collabSyngene · collab
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2019-09-11
- Completion
- 2019-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
Indications
No indication recorded.