NCT04064073已完成1 期
A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin 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: 2019年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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 of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
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 aged 19 to 50 years at the time of screening test
- •55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
- •Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
- •Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.
排除标准
- •Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- •Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- •Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
- •Clinical laboratory test values are outside the accepted normal range at screening
- •Other exclusive inclusion criteria, as defined in the protocol
研究组 & 干预措施
1
Experimental
干预措施: DWP16001 (Drug)
2
Experimental
干预措施: Metformin IR (Drug)
3
Experimental
干预措施: DWP16001+Metformin IR (Drug)
结局指标
主要结局
Cmax of DWP16001
时间窗: 0-72 hours
Peak Plasma Concetration
Cmax,ss of Metformin
时间窗: 0-144 hours
Peak Plasma Concetration at steady-state
AUClast of DWP16001
时间窗: 0-72 hours
Area under the plasma concentration versus time curve
AUCτ,ss of Metformin
时间窗: 0-144 hours
Area under the plasma concentration versus time curve at Tau, steady-state
次要结局
- Tmax of DWP 16001, Metformin, DWP16001 Metabolites(0-144 hours)
- T1/2 of DWP 16001, Metformin(0-144 hours)
- fe of DWP 16001, DWP16001 Metabolites(0-72 hours)
- AUC of DWP 16001, Metformin, DWP16001 Metabolites(0-144 hours)
- CL/F of DWP 16001, Metformin(0-144 hours)
- CLR of DWP 16001(0-144 hours)
研究者
研究点 (1)
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