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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBEC0101

Drug

Etanercept 25mg, single dose

Enbrel

Drug

Etanercept 25mg, single dose

Primary outcomes

Etanercept levels in blood

Time frame: 22 day

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Jun 17, 2010
Registry last updated: Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed