Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

LigaChem Biosciences, Inc.25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)DRUG

Oral administration

LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)DRUG

Oral administration

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Pharmacokinetic evaluation: The observed maximum concentration(Cmax)

Pharmacokinetic parameters will be assessed using non-compartmental method

Time frame: 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

Time frame: 0-12hours

Secondary Outcomes

Pharmacokinetic evaluation: Time to reach Cmax(Tmax)

Pharmacokinetic parameters will be assessed using non-compartmental method

Time frame: 0-12hours

Pharmacokinetic evaluation: Elimination half-life(t1/2)

Pharmacokinetic parameters will be assessed using non-compartmental method

Time frame: 0-12hours

Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F)

Pharmacokinetic parameters will be assessed using non-compartmental method

Time frame: 0-12hours

Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F)

Pharmacokinetic parameters will be assessed using non-compartmental method

Time frame: 0-12hours

Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf)

Area under the curve from time 0 extrapolated to infinite time

Time frame: 0-12hours

Data from ClinicalTrials.gov

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