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Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®

Healthy Clinical Trial

Official title:
Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers

Clinical Trial Summary

The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.

Clinical Trial Description

The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03659305
Study type Interventional
Source R-Pharm
Contact
Status Completed
Phase Phase 1
Start date July 10, 2018
Completion date January 26, 2019
View Details
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