Spots Global Cancer Trial Database for Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®

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Trial Identification

Brief Title: Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®

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

Study ID: NCT03659305

Conditions

Healthy

Interventions

RPH-001

Avastin

Study Description

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

Detailed 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.