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Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion

NCT02594761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2015-11-03

No results posted yet for this study

Summary

The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8 mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®. Secondary objectives included further pharmacokinetic assessment of similarity of Hercules, EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of safety (including immunogenicity) and local tolerance.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Hercules

Powder Concentrate for Intravenous Infusion, 150 mg/vial

BIOLOGICAL

Herceptin EU

Powder for Concentrate for Solution for Infusion, 150 mg/vial

BIOLOGICAL

Herceptin US

Intravenous Infusion, 440 mg/vial

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Apinya Vutikullird, D.O. · WCCT Global

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

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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 NCT02594761 on ClinicalTrials.gov