Comparison 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 status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Etanercept

Criteria

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