A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
研究概览
简要总结
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
详细描述
A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 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
- •Between 19 aged and 50 aged in healthy male adult
- •Body weight more than 55kg
- •Body Mass Index more than 18.5 and under 25
排除标准
- •Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
- •Have a gastrointestinal disease history that can effect drug absorption or surgery.
- •Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.
研究组 & 干预措施
Group A
Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
干预措施: CKD-381(formulation I) (Drug)
Group A
Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
干预措施: CKD-381(formulation II) (Drug)
Group A
Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
干预措施: D026(Nexium 40mg) (Drug)
Group B
Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
干预措施: CKD-381(formulation I) (Drug)
Group B
Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
干预措施: CKD-381(formulation II) (Drug)
Group B
Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
干预措施: D026(Nexium 40mg) (Drug)
Group C
Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
干预措施: CKD-381(formulation I) (Drug)
Group C
Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
干预措施: CKD-381(formulation II) (Drug)
Group C
Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
干预措施: D026(Nexium 40mg) (Drug)
结局指标
主要结局
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
时间窗: 0~24h
Evaluation PK esomeprazole after multiple dose
次要结局
- CL/F(Apparent clearance)(0~24h)
- Cmax,ss(Maximum concentration of drug in plasma at steady state)(0~24h)
- Tmax,ss(Time to maximum plasma concentration at steady state)(0~24h)
- t1/2(Terminal elimination half-life)(0~24h)
- Vss/F(Apparent Volume of distribution at steady state)(0~24h)
- Cmax(Maximum concentration of drug in plasma)(0~24h)
- AUClast(Area under the plasma drug concentration-time curve from 0 to last)(0~24h)
- Tmax(Time to maximum plasma concentration)(0~24h)
- Vd/F(Apparent volume of distribution)(0~24h)
- R(Accumulation ratio)(0~24h)
- CLss/F(Apparent Clearance at steady state)(0~24h)