Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: LB80380 maleate salt
* Drug: LB80380 free base


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LB80380 maleat salt<br> | Drug: LB80380 maleate salt<br>* 183 mg (150 mg as a free base)<br>|
| Active Comparator: LB80380 free base<br> | Drug: LB80380 free base<br>* 150 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | up to 144 hours | 
| Cmax |  | up to 144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Tmax, Aet, CL/F | up to 144 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LB80380, bioequivalence