Status:

COMPLETED

Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

Lead Sponsor:

Hanwha Chemical

Conditions:

Healthy

Eligibility:

MALE

20-40 years

Phase:

PHASE1

Brief Summary

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

Detailed Description

A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcuta...

Eligibility Criteria

Inclusion

  • 20 to 40 years of healthy volunteers
  • Weight over 55kg
  • Subject who signed on ICF

Exclusion

  • Subject who had been treated with Etanercept before

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT01431404

Start Date

August 1 2011

End Date

June 1 2013

Last Update

July 8 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul National University Hospital

Seoul, South Korea