## Protocol Section
### Identification Module
**NCT ID:** NCT04939779

**Brief Title:** Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

**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

#### Organization Study ID Info
**ID:** LCB01-0371-18-1-08
#### Organization
**Class:** INDUSTRY
**Full Name:** LigaChem Biosciences, Inc.
### Status Module
#### Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-25

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-01-24

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-14

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2021-06-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-21
**Study First Submit QC Date:** 2021-06-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** LigaChem Biosciences, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

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

**Label:** Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

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

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

**Label:** Group B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

- Group B

**Description:** Oral administration

**Name:** LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group A

- Group B

**Description:** Oral administration

**Name:** LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Pharmacokinetic parameters will be assessed using non-compartmental method

**Measure:** Pharmacokinetic evaluation: The observed maximum concentration(Cmax)

**Time Frame:** 0-12hours

**Description:** Area under the plasma concentration curve from zero until the last measurable concentration

**Measure:** Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)

**Time Frame:** 0-12hours

#### Secondary Outcomes

**Description:** Pharmacokinetic parameters will be assessed using non-compartmental method

**Measure:** Pharmacokinetic evaluation: Time to reach Cmax(Tmax)

**Time Frame:** 0-12hours

**Description:** Pharmacokinetic parameters will be assessed using non-compartmental method

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

**Time Frame:** 0-12hours

**Description:** Pharmacokinetic parameters will be assessed using non-compartmental method

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

**Time Frame:** 0-12hours

**Description:** Pharmacokinetic parameters will be assessed using non-compartmental method

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

**Time Frame:** 0-12hours

**Description:** Area under the curve from time 0 extrapolated to infinite time

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

**Time Frame:** 0-12hours

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 19 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seongnam-si

**Country:** Korea, Republic of

**Facility:** Seoul National University Bundang Hospital

**State:** Gyeonggi-do

**Zip:** 13620

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Bundang Hospital

**Name:** Jae-Yong Chung

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000011500

- Term: Protein Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M351859

- Name: Delpazolid

- Relevance: HIGH

- As Found: Penpulimab

- ID: M22872

- Name: Oxazolidinones

- Relevance: HIGH

- As Found: Penpulimab

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000627008

- Term: Delpazolid

- ID: D000023303

- Term: Oxazolidinones

### Misc Info Module

- Version Holder: 2024-05-24
