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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04360343
Other study ID # LG-SGCL003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2020
Est. completion date December 1, 2020

Study information

Verified date January 2021
Source LG Chem
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy males and females between the age of 19 and 45 at the screening visit 2. Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit 3. Subjects who were confirmed to be healthy based on the medical history 4. Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent Exclusion Criteria: 1. 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 2. 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 3. Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit 4. 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 5. Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day 6. 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 7. 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) 8. 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) 9. 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 10. Subjects who unable to take the food provided by the study institution 11. Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test) 12. Other cases that the investigator consider unsuitable as the subject

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Film-coated tablet
uncoated tablet

Locations

Country Name City State
Korea, Republic of Seoul National University College of Medicine and Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic Outcome Measures Peak Plasma Concentration (Cmax) baseline,during the procedure
Primary Pharmacokinetic Outcome Measures Area under the plasma concentration versus time curve (AUC) baseline,during the procedure
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