A Phase I Clinical Trial to Evaluate the Safety and Drug Interactions Between DWP16001 and in Combination With DWC202204 and DWC202205 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 53
- 主要终点
- AUCtau,ss of DWC202204 and DWC202205
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 , DWC202204 and DWC202205 alone or in combination in healthy male adults.
详细描述
* Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule.
After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 male adults ≥ 19 years of age at the time of the screening procedure
- •18.5 ≤ 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
Experimental 1
干预措施: DWP16001 (Drug)
Experimental 2
干预措施: DWC202204+DWC202205 (Drug)
Experimental 3
干预措施: DWP16001+DWC202204+DWC202205 (Drug)
结局指标
主要结局
AUCtau,ss of DWC202204 and DWC202205
时间窗: [Time Frame: 0-24 hours]
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWP16001
时间窗: [Time Frame: 0-72 hours]
Peak Plasma Concetration at steady-state
AUCtau,ss of DWP16001
时间窗: [Time Frame: 0-72 hours]
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202204 and DWC202205
时间窗: [Time Frame: 0-24 hours]
Peak Plasma Concetration at steady-state
次要结局
未报告次要终点