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 recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01635686
First received: July 4, 2012
Last updated: July 25, 2012
Last verified: July 2012

July 4, 2012
July 25, 2012
September 2012
June 2013   (final data collection date for primary outcome measure)
Etanercept levels in blood [ Designated as safety issue: No ]
Etanercept levels (AUClast, Cmax) in blood [ Time Frame: 21 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01635686 on ClinicalTrials.gov Archive Site
Not Provided
Etanercept levels (AUCinf, Tmax, t1/2, CL/F) in blood
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Rheumatoid Arthritis
  • Drug: DWP422 25mg
  • Drug: ENBREL 25MG PFS INJ.
  • Experimental: DWP422
    Intervention: Drug: DWP422 25mg
  • Active Comparator: ENBREL
    Intervention: Drug: ENBREL 25MG PFS INJ.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
38
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact: Kyung-Sang Yu ksyu@snu.ac.kr
Korea, Republic of
 
NCT01635686
DW_DWP422001
Not Provided
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP