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OpenTrials
Completed

NCT Number: NCT01725620

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

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

Completed

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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, Clinical Trial Center

Seoul, 110-744, 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 of latent tuberculosis patient
  • Hypersensitivity response to the test and comparator drugs

Treatment and study plan

LBEC0101 (Etanercept 25mg)

Drug

Enbrel (Etanercept 25mg)

Drug

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 Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 14, 2012
Registry last updated
Jan 30, 2015

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.

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