Status:
COMPLETED
Phase 1 Study in Diabetes Mellitus(Fed)
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Diabetes
Diabete Mellitus
Eligibility:
MALE
19+ years
Phase:
PHASE1
Brief Summary
An open-label, randomized, Fed, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
Detailed Description
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 HUC...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06551740
Start Date
April 15 2024
End Date
June 10 2024
Last Update
August 13 2024
Active Locations (1)
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1
Huons
Seongnam-si, Gyeonggi-do, South Korea, 13486