Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®
Information source: LG Life Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: LBEC0101 (Drug); Enbrel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: LG Life Sciences Official(s) and/or principal investigator(s): Kyung-Sang Yu, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University College of Medicine and Hospital
Summary
To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator,
Enbrel® 25 mg.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Etanercept levels in blood
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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 and Contacts
Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: June 2010
Last updated: February 17, 2011
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