NCT03726866Unknown1 期
A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax(Maximum plasma concentration of the drug at steady state)
研究概览
简要总结
To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between ≥ 19 and ≤ 40 years old
- •Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
- •Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
- •Subject who agree not to provide sperm
- •Subject who voluntarily agree to participate in this study
排除标准
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion
- •Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
- •Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- •Subject who have received other clinical trial drugs within 90 days prior to the screening visit
- •Any clinically significant active chronic disease
研究组 & 干预措施
Sequence 2
Experimental
Sequence 2
干预措施: Sequence 2 (Drug)
Sequence 1
Experimental
Sequence 1
干预措施: Sequence 1 (Drug)
Sequence 3
Experimental
Sequence 3
干预措施: Sequence 3 (Drug)
Sequence 4
Experimental
Sequence 4
干预措施: Sequence 4 (Drug)
Sequence 5
Experimental
Sequence 5
干预措施: Sequence 5 (Drug)
Sequence 6
Experimental
Sequence 6
干预措施: Sequence 6 (Drug)
结局指标
主要结局
Cmax(Maximum plasma concentration of the drug at steady state)
时间窗: at Day 9
PK parameters of D326, D337 and CKD-828
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
时间窗: at Day 9
PK parameters of D326, D337 and CKD-828
次要结局
- Tmax(Time to maximum plasma concentration at steady state)(at Day 9)
- t1/2(Terminal elimination half-life)(at Day 9)
研究者
研究点 (1)
Loading locations...
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