Phase 1 Study in Diabetes Mellitus(Fed)

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers.

Inclusion criteria

• Healthy adult aged over 19 at screening
• Those whose BMI is between 18kg/m2 and 30kg/m2
• Those weight over 50kg(female 45kg)
• Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion criteria

• Those who have clinically significant diseases or medical history below lists.

• Skin/mucous membranes
• Head and neck
• Eyes/appendages
• Ear, nose, and throat
• Thyroid/endocrine system
• Lungs/respiratory system
• Heart/circulatory system
• Abdomen/digestive system
• Kidney/urinary reproductive system
• Spine/musculoskeletal system
• Nervous/psychiatric system
• Blood/lymph/tumor
• Allergy/immune system
• Drug hypersensitivity
• Within 30 days prior to the first dose, the individual took medications significantly inducing or inhibiting drug-metabolizing enzymes such as barbiturates, or within 10 days prior to the first dose, took medications that could affect this study.
• Those who have participated in a bioequivalence study or other clinical trials and received investigational drugs within 6 months prior to the first dosing day.
• Within 8 weeks prior to the first dosing day, Those who have donated whole blood or within 2 weeks donated components, or received a blood transfusion within 4 weeks.
• Those who with a history of gastrointestinal resection surgery (excluding appendectomy or hernia repair) that could affect drug absorption, or those with gastrointestinal disorders.
• Within 1 month prior to the first dosing day, Those who meet the following conditions:

• For males, average alcohol consumption exceeding 21 drinks per week.
• For females, average alcohol consumption exceeding 14 drinks per week.
• Smoking more than an average of 20 cigarettes per day.
• Those who meet the following criteria:

• Known hypersensitivity reactions to active ingredients, excipients of investigational drugs, or non-quinolone drugs.
• Acute or chronic metabolic acidosis including type 1 diabetes mellitus, hyperglycemia, with or without ketoacidosis, or history of ketoacidosis.
• Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m² or severe and advanced renal impairment.
• End-stage renal disease or undergoing dialysis.
• Genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Acute conditions affecting renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis.
• Acute and unstable congestive heart failure.
• Receiving intravenous administration of iodinated contrast agents for radiographic studies.
• Diabetic ketoacidosis.
• Severe infections or severe systemic disorders.
• Malnutrition, starvation, cachexia, hypothalamic-pituitary dysfunction, or adrenal insufficiency.
• Acute or chronic conditions causing tissue hypoxia such as hepatic dysfunction, respiratory failure, acute myocardial infarction, shock, excessive alcohol consumption, dehydration, diarrhea, vomiting, or gastrointestinal disorders.
• Other reasons deemed unsuitable for participation in the clinical trial by the study investigator.
• For female subjects, pregnant, suspected pregnant, or lactating.