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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04939779

Enrollment

Registered

2021-06-25

Start date

2021-01-14

Completion date

2021-02-01

Last updated

2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGLCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

Oral administration

DRUGLCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic evaluation: The observed maximum concentration(Cmax)	0-12hours	Pharmacokinetic parameters will be assessed using non-compartmental 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

Secondary

Measure	Time frame	Description
Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F)	0-12hours	Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation: Time to reach Cmax(Tmax)	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
Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F)	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026