NCT01427868

Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

An Open-label, Phase I Study in Healthy Male Subjects to Compare the Pharmacokinetics of LB80331 and LB80317, Metabolites of LB80380, After a Single Oral Administration of LB80380 Free Base 150 mg (60 mg + 90 mg) Tablet or LB80380 Maleate Tablet 183 mg (150 mg as a Free Base)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	LB80380 maleate salt	183 mg (150 mg as a free base)
DRUG	LB80380 free base	150 mg

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2011-09-02
• Last updated: 2011-09-02

Locations

1 site across 1 country: South Korea