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

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.
 
ClinicalTrials.gov Identifier: NCT01145950
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
LG Life Sciences

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

Condition or disease Intervention/treatment Phase
Healthy Drug: LBEC0101 Drug: Enbrel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : June 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Group 1 Drug: LBEC0101
Etanercept 25mg, single dose

Experimental: Group 2 Drug: Enbrel
Etanercept 25mg, single dose




Primary Outcome Measures :
  1. Etanercept levels in blood [ Time Frame: 22 day ]


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 or latent tuberculosis patient
  • Hypersensitivity response to the test and comparator drugs

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): NCT01145950


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
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Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University College of Medicine and Hospital
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Responsible Party: Kim, Sung Il / Assistant Manager, Clinical Trial Team
ClinicalTrials.gov Identifier: NCT01145950    
Other Study ID Numbers: LG-ECCL001
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011
Keywords provided by LG Life Sciences:
Etanercept
Enbrel
healthy volunteers
Additional relevant MeSH terms:
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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