Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers

Phase 1

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: DWP422 25mg; Drug: ENBREL 25MG PFS INJ.

• Registration Number: NCT01635686
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26
• Study Start: 2012-09
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 38

Inclusion Criteria

1. Healthy males, 20 to 45 years of age the moment of screening
2. Body mass index is between 19.0 and 27.0 kg/m2

Exclusion Criteria

1. Hypersensitivity response to the experimental and comparator drugs
2. The tuberculosis patient or latent tuberculosis patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DWP422	DWP422 25mg	-
ENBREL	ENBREL 25MG PFS INJ.	-

Primary Outcome Measures

Name	Time	Method
Etanercept levels in blood

Trial Locations

Locations (1)

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