We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT01431404
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Etanercept (Enbrel) Biological: HD203 Phase 1

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 subcutaneous injection.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator
Study Start Date : August 2011
Primary Completion Date : March 2012
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Enbrel, prefilled syringe Biological: Etanercept (Enbrel)
prefilled syringe, SC
Experimental: HD203, prefilled syringe Biological: HD203
HD203, prefilled syringe, SC injection

Outcome Measures

Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 49days ]

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject who had been treated with Etanercept before
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): NCT01431404

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

Responsible Party: Hanwha Chemical
ClinicalTrials.gov Identifier: NCT01431404     History of Changes
Other Study ID Numbers: EAGLE-I-11
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors