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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1
Seoul National University Hospital
Seoul, South Korea