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Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers (SPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044836
First Posted: January 8, 2010
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanwha Chemical
  Purpose
The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 with those of etanercept after subcutaneous injection in healthy male volunteers.

Condition Intervention Phase
Healthy Biological: HD203 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

Further study details as provided by Hanwha Chemical:

Primary Outcome Measures:
  • Etanercept levels in blood [ Time Frame: 21 days ]

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept Biological: HD203
Injectable form

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 40 years of healthy volunteers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044836


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanwha Chemical
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital
  More Information

Responsible Party: Hanwha Chemical
ClinicalTrials.gov Identifier: NCT01044836     History of Changes
Other Study ID Numbers: EAGLE-I-09
First Submitted: January 5, 2010
First Posted: January 8, 2010
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Hanwha Chemical:
Healthy volunteer