NCT01145950

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• 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 the active comparator, Enbrel® 25 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LBEC0101	Etanercept 25mg, single dose
DRUG	Enbrel	Etanercept 25mg, single dose

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2010-06-17
• Last updated: 2011-02-18

Locations

1 site across 1 country: South Korea