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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

Page last updated: February 07, 2013

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