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

Phase 1CompletedNCT01145950

LG Life Sciences36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LBEC0101DRUG

Etanercept 25mg, single dose

EnbrelDRUG

Etanercept 25mg, single dose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Etanercept levels in blood

Time frame: 22 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.