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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01635686

Enrollment

Registered

2012-07-09

Start date

2012-09-30

Completion date

2013-06-30

Last updated

2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGDWP422 25mg

DRUGENBREL 25MG PFS INJ.

Study design

Allocation

RANDOMIZED

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Etanercept levels in blood	—

Countries

South Korea

Contacts

Primary ContactKyung-Sang Yu

ksyu@snu.ac.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026