Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R); Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 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
2. A healthy adult whose weight is over 50 kg
3. 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:

1. 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.
2. A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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); Oral administration; Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006); Oral administration
Experimental: Group B; 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); Oral administration; Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006); Oral administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LegoChem Biosciences, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): January 24, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Delpazolid; Oxazolidinones
• Other Study ID Numbers: LCB01-0371-18-1-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No