- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145950
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®
February 17, 2011 updated by: LG Life Sciences
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
To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
|
Etanercept 25mg, single dose
|
EXPERIMENTAL: Group 2
|
Etanercept 25mg, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Etanercept levels in blood
Time Frame: 22 day
|
22 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (ESTIMATE)
June 17, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 17, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-ECCL001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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