Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2012
CompletedFirst Posted
Study publicly available on registry
July 9, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 26, 2012
July 1, 2012
9 months
July 4, 2012
July 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Etanercept levels in blood
Study Arms (2)
DWP422
EXPERIMENTALENBREL
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy males, 20 to 45 years of age the moment of screening
- Body mass index is between 19.0 and 27.0 kg/m2
You may not qualify if:
- Hypersensitivity response to the experimental and comparator drugs
- The tuberculosis patient or latent tuberculosis patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2012
First Posted
July 9, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 26, 2012
Record last verified: 2012-07