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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: ENBREL 25MG PFS INJ.; Drug: DWP422 25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01635686

DW_DWP422001

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

38 participants in 2 patient groups

DWP422

Experimental group

Treatment:

Drug: DWP422 25mg

ENBREL

Active Comparator group

Treatment:

Drug: ENBREL 25MG PFS INJ.