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

Information source: LG Life Sciences
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: LBEC0101 (Drug); Enbrel (Drug)

Phase: Phase 1

Status: Not yet 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 Hospital

Summary

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

Clinical Details

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 design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Etanercept levels in blood

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 or latent tuberculosis patient

- Hypersensitivity response to the test and comparator drugs

Locations and Contacts

Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: June 2010
Last updated: June 16, 2010

Page last updated: October 04, 2010

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