Phase 1 study to evaluate the safety and the pharmacokinetics of "UI061" and "UIC202006" in healthy adult volunteers under fed state conditions

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Drug : Group A: R(1)‐T(2)‐R(3)‐T(4) Group B: T(1)‐R(2)‐T(3)‐R(4) *Arm R: UIC202006, once *Arm T: UI061, once CONDITION: Endocrine, nutritional and metabolic diseases PRIMARY OUTCOME: Adverse events, concomitant medications, vital signs, diagnostic tests, electrocardiograms, physical examinations AUCt, Cmax SECONDARY OUTCOME: AUC8, Tmax, t1/2 INCLUSION CRITERIA: 1) Those aged 19 years or older at the time of screening visit 2) Subjects with a weight of 50 kg or more (45 kg or more for women) and a body mass inde X(BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less at the screening visit ? BMI (kg/m2) = weight (kg)/{height (m)}2 3) Those who have no clinically significant congenital or chronic diseases at the screening visit and no pathological symptoms or findings as a result of internal medical examination 4) Diagnosis tests such as hematology test, blood chemistry test, serum test, urine test, etc. and electrocardiogram test, which are set and conducted by the trial director (or the commissioned study doctor) according to the characteristics of the investigational product, and are determined to be suitable as test subjects ruler 5) From the first dose of investigational product to 7 days after the last dose of investigational product who agreed to * Methods of contraception accepted in clinical tria
Epistemonikos ID: 7f4b8414c0ee018896801f325e0af1b29bac9495
First added on: Feb 20, 2024