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A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects

NCT02927353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-08-22

No results posted yet for this study

Summary

To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects

Conditions

  • Healthy Volunteer

Interventions

DRUG

DMB-3113

subcutaneously injected in a single dose of 40 mg.

DRUG

Adalimumab

subcutaneously injected in a single dose of 40 mg.

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hideki Fushimi, Manager · Meiji Seika Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-01-17
Completion
2017-01-17

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 NCT02927353 on ClinicalTrials.gov