NCT01725620

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LBEC0101 (Etanercept 25mg)
DRUG	Enbrel (Etanercept 25mg)

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2014-04-01
• First posted: 2012-11-14
• Last updated: 2015-01-30

Locations

1 site across 1 country: South Korea