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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01725620
First received: November 9, 2012
Last updated: March 12, 2013
Last verified: March 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

Study Start Date: November 2012
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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01725620     History of Changes
Other Study ID Numbers: LG-ECCL003
Study First Received: November 9, 2012
Last Updated: March 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014