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Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults

NCT02100917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-02-10

No results posted yet for this study

Summary

This study is a randomized Trastuzumab-controlled double-blind parallel-group study.

Conditions

  • Healthy Volunteer

Interventions

DRUG

DMB-3111

DRUG

trastuzumab

Sponsors & Collaborators

  • Dong-A Pharmaceutical

    collaborator INDUSTRY

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • Japan

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 NCT02100917 on ClinicalTrials.gov