A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of the Fixed-dose Combination of DWJ1563 Compared to the Loose Combination of DWP16001 and DWC202213
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUC0-t of DWP16001
研究概览
简要总结
To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Chungbuk University Hospital to participate in this study according to his free will.
- •Healthy adults aged 19 or older at the time of screening.
- •Those who weigh more than 50.0 kg in men and women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women.
- •Body mass index (BMI) = Weight (kg) / [Height (m)] 2.
排除标准
- •A person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc.
- •A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia).
- •Those who are hypersensitive to other drugs (DPP-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including DWP16001, DWC202213 and homogeneous (SGLT2 inhibitors)
- •A person who shows the following results in the inspection items conducted during screening.
- •Blood ALT, AST, Total bilirubin > twice the upper limit of the normal range.
- •The glomerular filtration rate (e-GFR) <90 mL/min/1.73 m2 (using the CKD-EPI method)
- •After more than 3 minutes of rest, systolic blood pressure > 150 mmHg or <90 mmHg, or diastolic blood pressure > 100 mmHg or <60 mmHg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat
研究组 & 干预措施
Group B
administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
干预措施: DWP16001 (Drug)
Group A
administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
干预措施: DWC202213 (Drug)
Group A
administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
干预措施: DWJ1563 (Drug)
Group A
administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
干预措施: DWP16001 (Drug)
Group B
administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
干预措施: DWC202213 (Drug)
Group B
administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
干预措施: DWJ1563 (Drug)
结局指标
主要结局
AUC0-t of DWP16001
时间窗: 0 to 24 hours
AUC0-t of DWP16001
AUC0-t of DWC202213
时间窗: 0 to 24 hours
AUC0-t of DWC202213
Cmax of DWP16001
时间窗: 0 to 24 hours
Cmax of DWP16001
Cmax of DWC202213
时间窗: 0 to 24 hours
Cmax of DWC202213
次要结局
未报告次要终点