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

This study has been completed.
Information provided by (Responsible Party):
LG Life Sciences Identifier:
First received: November 9, 2012
Last updated: January 29, 2015
Last verified: January 2015
To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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)


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

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
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Please refer to this study by its identifier: NCT01725620

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

Responsible Party: LG Life Sciences Identifier: NCT01725620     History of Changes
Other Study ID Numbers: LG-ECCL003
Study First Received: November 9, 2012
Last Updated: January 29, 2015

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors processed this record on May 25, 2017