NCT06551740已完成1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
An open-label, randomized, Fed, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2
Experimental
Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break.
干预措施: HUC2-344 (Drug)
After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2
Experimental
Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break.
干预措施: HUC2-344-R1, HUC2-344-R2 (Drug)
After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.
Experimental
Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break.
干预措施: HUC2-344 (Drug)
After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.
Experimental
Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break.
干预措施: HUC2-344-R1, HUC2-344-R2 (Drug)
结局指标
主要结局
AUCt
时间窗: 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
Area under the drug concentration-time curve
Cmax
时间窗: 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
Maximum concentration of HUC2-344
Tmax
时间窗: 0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
Time of concentration
次要结局
未报告次要终点
研究者
研究点 (1)
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