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
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 April 17, 2014