NCT07213310已完成1 期
A Phase 1, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 on the Pharmacokinetics of DWP16001 and Its Metabolite in Healthy Adult Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年11月9日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
详细描述
A phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of DWC202511 or DWC202512 on the pharmacokinetics of DWP16001 and its metabolite in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 50 years at the time of screening.
- •50.0 kg ≤ Body weight ≤ 90.0 kg and 18.5 ≤ Body Mass Index (BMI) ≤ 29.9 kg/m² at the time of screening.
- •Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study, etc.
排除标准
- •Currect or history of clinically significant hepatic, renal, kidney, nervous, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic conditions, cardiovascular, genitourinary, psychiatric, or sexual disorders.
- •History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, gastritis, gastric spasms, gastroesophageal reflux disease) or surgeries (excluding simple appendectomy or hernia repair) that may affect the safety, pharmacokinetics, or pharmacodynamics of the investigational product.
- •Current or history of gastrointestinal disorders or prior gastrointestinal surgery (except appendectomy or hernia repair) that may affect safety or PK/PD assessment of the investigational product.
- •Current or history of urinary tract infection or genital fungal infection.
- •Current or history of metabolic acidosis, such as diabetic ketoacidosis.
- •Genetic disorders including galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
研究组 & 干预措施
Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001
Experimental
干预措施: DWC202511 (Drug)
Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001
Experimental
干预措施: DWC202512 (Drug)
Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001
Experimental
干预措施: DWP16001 (Drug)
结局指标
主要结局
Cmax
时间窗: 1 week
AUClast
时间窗: 1 week
次要结局
- AUCinf(1 week)
- t1/2(1 week)
- Tmax(1 week)
- CL/F(1 week)
- Vz/F(1 week)
- metabolic ratio(1 week)
研究者
研究点 (1)
Loading locations...
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