NCT06165965已完成1 期
A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC over24H of JLP-2008
研究概览
简要总结
To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008
详细描述
A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the co-administration of JT-001, and JT-002 for healthy subjects in fasted state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 19 and 55 years of age at the time of screening test
- •At the time of the screening test, a subject weighing more than 50 kg for men and 45 kg for women, and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
- •After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decide to participate and give written consent before the screening procedure
排除标准
- •Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
- •Those who have clinically siginificant medical history of liver (severe liver disorders, etc.), kidneys (severe renal disorders, etc.), digestive system (pancreatitis, etc.), respiratory system, musculoskeletal system, endocrine system (diabetic ketoacidosis, diabetic coma and precoma, type 1 Diabetes mellitus), neuropsychiatric, hematologic/oncological, and cardiovascular (heart failure, orthostatic hypotension, etc.)
- •Those with a history of Gastrointestinal disease (e.g. Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids, dentition, and fistula surgery) that may affect the absorption of the investigational product
- •Persons judged to be unsuitable as trial subjects in the test items conducted during screening
- •Blood ALT, AST, Total bilirubin > 2 times the upper limit of normal range
- •eGFR < 60 mL/min/1.73m2 (using CKD-EPI formula)
- •HBsAg, HCV Ab, HIV, Syphilis regain test (RPR) results are positive
- •Vital signs measured in the sitting position after resting for more than 3 minutes: systolic blood pressure > 160 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg
研究组 & 干预措施
Treatment(Experimental): JLP-2008
Experimental
- Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002])
干预措施: SGLT2 inhibitor (Drug)
Control(Active Comparator): JC-013
Active Comparator
- Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002])
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
AUC over24H of JLP-2008
时间窗: 24 hours
Cmax of JLP-2008
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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