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Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

Hepatitis B Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01427868
Study type Interventional
Source LG Life Sciences
Contact
Status Completed
Phase Phase 1
Start date September 2010
Completion date December 2010
View Details
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