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Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725620
First Posted: November 14, 2012
Last Update Posted: January 30, 2015
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.
Information provided by (Responsible Party):
LG Life Sciences
  Purpose
To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.

Condition Intervention Phase
Healthy Drug: LBEC0101 (Etanercept 25mg) Drug: Enbrel (Etanercept 25mg) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Enrollment: 48
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Enbrel, LBEC0101
Drug: LBEC0101 (Etanercept 25mg) Drug: Enbrel (Etanercept 25mg)
Experimental: Group 2
LBEC0101, Enbrel
Drug: LBEC0101 (Etanercept 25mg) Drug: Enbrel (Etanercept 25mg)

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy males, 20 to 45 years of age the moment of screening
  • Body mass index is between 18.0 and 30.0 kg/m

Exclusion Criteria:

  • The tuberculosis patient of latent tuberculosis patient
  • Hypersensitivity response to the test and comparator drugs
  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): NCT01725620


Locations
Korea, Republic of
Seoul National University Hospital, Clinical Trial Center
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University College of Medicine and Hospitaal
  More Information

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01725620     History of Changes
Other Study ID Numbers: LG-ECCL003
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: January 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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