Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-02-01

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Oral administration

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

Intervention Type DRUG

Oral administration

Group B

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Oral administration

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

Intervention Type DRUG

Oral administration

Interventions

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

Oral administration

Intervention Type DRUG

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

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes