Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R); Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

• Registration Number: NCT04939779
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-14
• Primary Completion: 2021-01-24
• Study Completion: 2021-02-01
• Study First Submitted: 2021-02-21
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)	Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
Group A	LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)	Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
Group B	LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)	Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)
Group B	LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)	Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of