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
Subjects aged 19 years or older and less than 55 years at the screening visit.
Subjects with a body weight of at least 50 kg (at least 45 kg for females) and a body mass index (BMI) of 18.0 kg/m² or higher and 30.0 kg/m² or lower at the screening visit.
Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examination at the screening visit.
Subjects determined to be eligible for participation in the clinical trial by the Investigator (or delegated Sub-investigator) based on the evaluation results of hematology, blood chemistry, serology, urinalysis, other clinical laboratory tests, physical examination, and electrocardiogram (ECG), which are established and performed according to the characteristics of the investigational product.
Subjects with current or past history of clinically significant diseases involving the renal system (e.g., severe renal impairment), nervous system (e.g., cerebrovascular disease), immune system, respiratory system (e.g., bronchial asthma), urinary system, gastrointestinal system, endocrine system (e.g., congenital lipid metabolism disorders, severe diabetes mellitus), hematologic/oncologic system, cardiovascular system (e.g., severe hypertension, heart failure, coronary artery disease), reproductive system (e.g., endometrial hyperplasia, endometriosis), psychiatric disorders, or myopathy.
Subjects with a history of gastrointestinal surgery (except simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal disease.
Subjects with severe hepatic impairment, biliary obstruction, or cholestasis (this drug is excreted almost entirely via bile. Cholestasis, biliary obstructive disease, or hepatic impairment may be expected to reduce hepatic clearance.).
Subjects with active liver disease or persistent elevation of aminotransferase levels of unknown cause.