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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01635686
• Other study ID #: DW_DWP422001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 4, 2012
• Last updated: July 25, 2012
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Kyung-Sang Yu
• Email: ksyu[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• DWP422 25mg

• ENBREL 25MG PFS INJ.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Etanercept levels in blood			No