An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
研究概览
简要总结
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
详细描述
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- •Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- •Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- •Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
排除标准
- •History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- •With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion
- •Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- •Any clinically significant active chronic disease
研究组 & 干预措施
Part A, Sequence1
- Period 1: Treatment of D013, D326 and D337 on Day1~Day7
- Period 2: Treatment of D013 on Day22~Day28
干预措施: D013, D326 and D337 (Drug)
Part A, Sequence1
- Period 1: Treatment of D013, D326 and D337 on Day1~Day7
- Period 2: Treatment of D013 on Day22~Day28
干预措施: D013 (Drug)
Part A, Sequence 2
- Period 1: Treatment of D013 on Day1~Day7
- Period 2: Treatment of D013, D326 and D337 on Day22~Day28
干预措施: D013, D326 and D337 (Drug)
Part A, Sequence 2
- Period 1: Treatment of D013 on Day1~Day7
- Period 2: Treatment of D013, D326 and D337 on Day22~Day28
干预措施: D013 (Drug)
Part B, Sequence 1
- Period 1: Treatment of D013, D326 and D337 on Day1~Day7
- Period 2: Treatment of D326 and D337 on Day22~Day28
干预措施: D013, D326 and D337 (Drug)
Part B, Sequence 1
- Period 1: Treatment of D013, D326 and D337 on Day1~Day7
- Period 2: Treatment of D326 and D337 on Day22~Day28
干预措施: D326 and D337 (Drug)
Part B, Sequence 2
- Period 1: Treatment of D326 and D337 on Day1~Day7
- Period 2: Treatment of D013, D326 and D337 on Day22~Day28
干预措施: D013, D326 and D337 (Drug)
Part B, Sequence 2
- Period 1: Treatment of D326 and D337 on Day1~Day7
- Period 2: Treatment of D013, D326 and D337 on Day22~Day28
干预措施: D326 and D337 (Drug)
结局指标
主要结局
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
时间窗: 0(predose)~24 hours at Day7 and Day28
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Cmax,ss(Maximum plasma concentration of the drug at steady state)
时间窗: 0(predose)~24 hours at Day7 and Day28
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
次要结局
- PTF(Peak-to-trough fluctuation)(0(predose)~24 hours at Day7 and Day28)
- Vd,ss/F(Apparent volume of distribution at steady state)(0(predose)~24 hours at Day7 and Day28)
- t1/2(Terminal elimination half-life)(0(predose)~24 hours at Day7 and Day28)
- Tmax,ss(Time to maximum plasma concentration at steady state)(0(predose)~24 hours at Day7 and Day28)
- Cmin,ss(Minimum concentration of the drug in plasma at steady state)(0(predose)~24 hours at Day7 and Day28)
- CLss/F(Apparent total body clearance of the drug from plasma at steady state)(0(predose)~24 hours at Day7 and Day28)