NCT04343547Unknown1 期
A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cmax of DWP16001
研究概览
简要总结
The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure
- •55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0
- •Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information
- •Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.
排除标准
- •Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
- •Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.
- •Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)
- •Considered ineligible for the study by the investigator for reasons including laboratory test results
研究组 & 干预措施
1
Experimental
干预措施: DWP16001 (Drug)
2
Experimental
干预措施: DWC202001+DWC202002 (Drug)
Experimental 3
Experimental
干预措施: DWP16001+DWC202001+DWC202002 (Drug)
结局指标
主要结局
Cmax of DWP16001
时间窗: 0-72 hours
Peak Plasma Concetration
AUCτ,ss of DWC202001 and DWC202002
时间窗: 0-72 hours
Area under the plasma concentration versus time curve at Tau, steady-state
AUClast of DWP16001
时间窗: 0-72 hours
Area under the plasma concentration versus time curve
Cmax,ss of DWC202001 and DWC202002
时间窗: 0-72 hours
Peak Plasma Concetration at steady-state
次要结局
- T1/2 of DWP 16001, DWC202001 and DWC202002(0-72 hours)
- CL/F of DWC202001 and DWC202002(0-72 hours)
- Tmax of DWP 16001, DWC202001 and DWC202002(0-72 hours)
研究者
研究点 (1)
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