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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
Sponsor:
Information provided by (Responsible Party):

September 5, 2011
September 9, 2011
July 8, 2013
August 2011
March 2012   (Final data collection date for primary outcome measure)
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 ]
Composite of Pharmacokinetics [ Time Frame: 0 h(pre-dose), 3, 6, 12, 24, 36, 48, 60, 72, 96, 144, 216, 312, 480 h post-dose ]
Etanercept Pharmacokinetics: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F
Complete list of historical versions of study NCT01431404 on ClinicalTrials.gov Archive Site
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Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects
Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Biological: Etanercept (Enbrel)
    prefilled syringe, SC
  • Biological: HD203
    HD203, prefilled syringe, SC injection
  • Active Comparator: Enbrel, prefilled syringe
    Intervention: Biological: Etanercept (Enbrel)
  • Experimental: HD203, prefilled syringe
    Intervention: Biological: HD203
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2013
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01431404
EAGLE-I-11
No
Not Provided
Not Provided
Hanwha Chemical
Hanwha Chemical
Not Provided
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital
Hanwha Chemical
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP