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Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431404
First Posted: September 9, 2011
Last Update Posted: July 8, 2013
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 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

Condition Intervention Phase
Healthy Biological: Etanercept (Enbrel) 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: Treatment
Official Title: Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator

Resource links provided by NLM:


Further study details as provided by Hanwha Chemical:

Primary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enbrel, prefilled syringe Biological: Etanercept (Enbrel)
prefilled syringe, SC
Experimental: HD203, prefilled syringe Biological: HD203
HD203, prefilled syringe, SC 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 subcutaneous injection.
  Eligibility

Information from the National Library of Medicine

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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
  • 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


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: NCT01431404     History of Changes
Other Study ID Numbers: EAGLE-I-11
First Submitted: September 5, 2011
First Posted: September 9, 2011
Last Update Posted: July 8, 2013
Last Verified: July 2013

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