We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01635686
Recruitment Status : Unknown
Verified July 2012 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: DWP422 25mg Drug: ENBREL 25MG PFS INJ. Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Masking: Double
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
Study Start Date : September 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DWP422 Drug: DWP422 25mg
Active Comparator: ENBREL Drug: ENBREL 25MG PFS INJ.


Outcome Measures

Primary Outcome Measures :
  1. Etanercept levels in blood

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635686


Contacts
Contact: Kyung-Sang Yu ksyu@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyung-Sang Yu       ksyu@snu.ac.kr   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01635686     History of Changes
Other Study ID Numbers: DW_DWP422001
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors