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OpenTrials
Completed

NCT Number: NCT04360343

Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University College of Medicine and Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males and females between the age of 19 and 45 at the screening visit
  • Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
  • Subjects who were confirmed to be healthy based on the medical history
  • Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent

Exclusion criteria

  • Subjects with a clinically significant disease or history in liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system or cardiovascular system
  • Subjects with a disease (e.g., Crohn's disease, etc.) or history of surgery (except for simple appendectomy and herniotomy) in gastrointestinal system which may affect the absorption of the investigational product
  • Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
  • Subjects who had donated whole blood within 2 months, component blood within 1 month, or received transfusion within 1 month prior to the first administration day
  • Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
  • Subjects who had eaten grapefruit/caffeine-containing food within 3 days prior to the first hospitalization or subjects who could not stop taking food containing grapefruit or caffeine from 3 days prior to hospitalization to the discharge day
  • Subjects who had taken any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator's discretion)
  • Subjects who taking excessive caffeine or alcohol or heavy smoker (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL as pure alcohol), smoking > 10 cigarettes/day)
  • Subjects who had a history of tuberculosis (TB) infection or a positive result in the Quantiferon TB-Gold test and the chest X-ray in the screening tests
  • Subjects who unable to take the food provided by the study institution
  • Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test)
  • Other cases that the investigator consider unsuitable as the subject

Treatment and study plan

Film-coated tablet

Drug

uncoated tablet

Primary outcomes

  1. Pharmacokinetic Outcome Measures

    Time frame: baseline,during the procedure

    Peak Plasma Concentration (Cmax)

  2. Pharmacokinetic Outcome Measures

    Time frame: baseline,during the procedure

    Area under the plasma concentration versus time curve (AUC)

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Jan 22, 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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