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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01427868

Enrollment

Registered

2011-09-02

Start date

2010-09-30

Completion date

2010-12-31

Last updated

2011-09-02

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

Conditions

Hepatitis B

Keywords

LB80380, bioequivalence

Brief 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.

Interventions

DRUGLB80380 maleate salt

183 mg (150 mg as a free base)

DRUGLB80380 free base

150 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Male with good health * 20 to 45 years of age at screening * Body weight ±20% of ideal body weight * Willingness and ability to comply with study procedures and communicate with investigators * Provided written consent voluntarily after informed of all the pertinent aspects of the trial

Exclusion criteria

* Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations * Clinically significant acute or chronic medical conditions * Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration * Participation in clinical trial within 3 months before the first day of drug administration * Alcohol abuse * Habitual smoker * Habitual user of herbal medicine * Use of grapefruit-containing food or grapefruit juice during the study period * Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test

Design outcomes

Primary

Measure	Time frame
AUC	up to 144 hours
Cmax	up to 144 hours

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability	up to 7 days	—
Profile of Pharmacokinetics	up to 144 hours	Tmax, Aet, CL/F

Countries

South Korea

Outcome results

None listed

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