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Completed

NCT Number: NCT04939779

Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

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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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • A healthy adult whose weight is over 50 kg
  • 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

  • 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.
  • A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Treatment and study plan

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

Drug

Oral administration

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

Drug

Oral administration

Primary outcomes

  1. Pharmacokinetic evaluation: The observed maximum concentration(Cmax)

    Time frame: 0-12hours

    Pharmacokinetic parameters will be assessed using non-compartmental method

  2. Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)

    Time frame: 0-12hours

    Area under the plasma concentration curve from zero until the last measurable concentration

Secondary outcomes

  1. Pharmacokinetic evaluation: Time to reach Cmax(Tmax)

    Time frame: 0-12hours

    Pharmacokinetic parameters will be assessed using non-compartmental method

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

    Time frame: 0-12hours

    Pharmacokinetic parameters will be assessed using non-compartmental method

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

    Time frame: 0-12hours

    Pharmacokinetic parameters will be assessed using non-compartmental method

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

    Time frame: 0-12hours

    Pharmacokinetic parameters will be assessed using non-compartmental method

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

    Time frame: 0-12hours

    Area under the curve from time 0 extrapolated to infinite time

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2021
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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