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

This study has been completed.
Sponsor:
Information provided by:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01145950
First received: June 15, 2010
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.


Condition Intervention Phase
Healthy
 Drug: LBEC0101
Drug: Enbrel
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Etanercept levels in blood [ Time Frame: 22 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: LBEC0101
Etanercept 25mg, single dose
Experimental: Group 2 Drug: Enbrel
Etanercept 25mg, single dose

  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 or latent tuberculosis patient
  • Hypersensitivity response to the test and comparator drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145950

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

No publications provided

Responsible Party: Kim, Sung Il / Assistant Manager, Clinical Trial Team
ClinicalTrials.gov Identifier: NCT01145950     History of Changes
Other Study ID Numbers: LG-ECCL001
Study First Received: June 15, 2010
Last Updated: February 17, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by LG Life Sciences:
Etanercept
Enbrel
healthy volunteers

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 May 19, 2013