Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939779
• Other study ID #: LCB01-0371-18-1-08
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2021
• Est. completion date: February 1, 2021

Study information

• Verified date: June 2021
• Source: LegoChem Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2021
• Est. primary completion date: January 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
Oral administration
• LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)
Oral administration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
LegoChem Biosciences, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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