A randomized, open-label, multiple-dose, crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers
Inclusion Criteria:
Healthy adult volunteers aged 19 years or older at the time of screening.
Weight and Body Mass Index (BMI) at screening as follows:
Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings based on medical examination.
Subjects judged suitable for the clinical trial based on laboratory tests, vital signs, physical examination, and 12-lead ECG conducted at screening.
Subjects who test negative for H.pylori antibody at screening.
Subjects who voluntarily decide to participate and provide written informed consent after being fully informed of and understanding the details of this clinical trial and the subject compliance requirements.
Exclusion Criteria:
Current or past history of clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal diseases.
History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy, hernia repair, or dental procedures) that may affect the absorption of the investigational product.
Pregnant (positive Urine-HCG test) or breastfeeding women.
History of clinically significant hypersensitivity (e.g., anaphylaxis or angioedema) to the investigational product ingredients, excipients, or other drugs (e.g., aspirin, penicillin-type antibiotics, macrolide antibiotics, etc.).
Clinically significant findings on 12-lead ECG at screening, including:
Clinically significant laboratory results at screening, including:
History of drug abuse or a positive response to drugs of abuse in the urine drug screen.
Vital signs measured in a sitting position after at least 3 minutes of rest at screening:
Abnormal diet or consumption of food that may affect the absorption, distribution, metabolism, and excretion (ADME) of the investigational product.
Use of any prescription drugs or herbal medicines within 2 weeks, or any over-the-counter (OTC) drugs or health functional foods within 10 days before the first dose (unless deemed by the investigator not to affect the PK of the investigational product).
Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month before the first dose.
Participation and dosing in another clinical trial within 6 months before the first dose.
Whole blood donation within 2 months, component donation within 1 month, or blood transfusion within 1 month before the first dose; or inability to refrain from donation during the study.
Consistent alcohol consumption exceeding 21 units/week (1 unit = 10g of pure alcohol) within 6 months before the first dose, or inability to abstain from alcohol during the study.
Smokers who averaged > 10 cigarettes/day within 3 months before the first dose, or inability to quit smoking from 48 hours before the first dose until the last PK blood collection.
Consumption of food containing grapefruit within 72 hours before the first dose, or inability to abstain during the study.
Consumption of food containing caffeine (coffee, tea, soda, etc.) from 48 hours before each first dose until the last PK blood collection, or inability to abstain.
Strenuous exercise exceeding normal daily activities within 72 hours before the first dose, or inability to refrain from such exercise.
Subjects (or their partners) planning pregnancy, or those not using medically accepted methods of contraception (e.g., hormonal contraceptives, IUD, sterilization, barrier methods) from the time of consent until 2 weeks after the last dose.
Any other reason the investigator deems the subject unsuitable for participation in the clinical trial.
mk_park@cbnuhctc.com+82432698708
A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects
A Study to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UI059 and UIC202201
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects
Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" Under Fed Conditions
A Clinical Study to Evaluate the Safety and the Pharmacokinetics of UI068 in Healthy Adult Volunteers Under Fed Conditions
A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
Study to Evaluate the Safety and PK of UI018