Study to Compare the Safery and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®
Information source: LG Life Sciences
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: LBEC0101 (Etanercept 25mg) (Drug); Enbrel (Etanercept 25mg) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: LG Life Sciences Official(s) and/or principal investigator(s):
Kyung-Sang Yu, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University College of Medicine and Hospitaal
Summary
To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,
Enbrel® 25mg.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Seoul National University Hospital, Clinical Trial Center, Seoul 110-744, Korea, Republic of; Recruiting
Li Young Ahn, Phone: 82-2-2072-1666, Email: helloahn@snu.ac.kr
Additional Information
Starting date: November 2012
Last updated: December 2, 2012
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