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Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Registration Number
NCT01894412
Lead Sponsor
Hanwha Chemical
Brief Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
48
Inclusion Criteria
  • 20 to 40 years of healthy volunteers
Exclusion Criteria
  • Subject who had been treated with Etanercept before

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinityup to 56 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of

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