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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725620

Enrollment

Registered

2012-11-14

Start date

2012-11-30

Completion date

2014-04-30

Last updated

2015-01-30

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

Conditions

Healthy

Brief summary

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

Interventions

DRUGLBEC0101 (Etanercept 25mg)

DRUGEnbrel (Etanercept 25mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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 of latent tuberculosis patient * Hypersensitivity response to the test and comparator drugs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026