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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01145950

Enrollment

Registered

2010-06-17

Start date

2010-06-30

Completion date

2011-01-31

Last updated

2011-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Etanercept, Enbrel, healthy volunteers

Brief summary

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

Interventions

DRUGLBEC0101

Etanercept 25mg, single dose

DRUGEnbrel

Etanercept 25mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Etanercept levels in blood	22 day

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026