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Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

NCT02469987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2022-03-25

No results posted yet for this study

Summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Conditions

  • Healthy

Interventions

DRUG

MYL-1402O

Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.

DRUG

US marketed Avastin(R)

Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins

DRUG

EU marketed Avastin(R)

Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew A. Hummel, PhD · Mylan Pharmaceuitcals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Netherlands

Study Locations

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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 NCT02469987 on ClinicalTrials.gov