Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

LigaChem Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04939779

LCB01-0371-18-1-08

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

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

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

Group B

Experimental group

Description:

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

Treatment:

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

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