Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

Study Overview
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Brief Summary
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The objective of this clinical trial is to evaluate bioequivalence of LCB01-0371 (Batch# 1650006) and LCB01-0371(Batch#3183817R) in healthy adult subject

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of LCB01-0371(Batch#1650006) and LCB01-0371(Batch#3183817R) in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
* Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person who is a healthy adult aged between 19 and 45 years old with the result of BMI between 18.0 kg/m2 and 28.0 kg/m2 A healthy adult whose weight is over 50 kg A person who is deemed suitable for a clinical trial subject in physical examination, vital sign tests, diagnostic examination, and 12-lead ECG by the medical doctor, etc. Exclusion Criteria: A person who has a clinically significant history of the disease, such as liver, kidney, gastrointestinal disease, respiratory tract disease, muscular-skeletal disease, endocrine disease, nervous system disease, blood ∙ tumor disease, cardiovascular disease, etc. A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Ages Eligible for Study
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Minimum Age: 19 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) | Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)<br>* Oral administration<br>Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)<br>* Oral administration<br>|
| Experimental: Group B<br>Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) | Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)<br>* Oral administration<br>Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluation: The observed maximum concentration(Cmax) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours | 
| Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast) | Area under the plasma concentration curve from zero until the last measurable concentration | 0-12hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluation: Time to reach Cmax(Tmax) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours | 
| Pharmacokinetic evaluation: Elimination half-life(t1/2) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours | 
| Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours | 
| Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours | 
| Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf) | Area under the curve from time 0 extrapolated to infinite time | 0-12hours |