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

NCT03659305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-02-05

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

BIOLOGICAL

RPH-001

Concentrate for preparation solution for infusion in ampules, 25 mg/mL

BIOLOGICAL

Avastin

Concentrate for preparation solution for infusion in ampules, 25 mg/mL

Sponsors & Collaborators

  • Almedis

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-01-26
Completion
2019-01-26

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659305 on ClinicalTrials.gov