A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUCτ,ss
研究概览
简要总结
A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults
详细描述
- To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
- To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Subjects does not meet the Inclusion Criteria
研究组 & 干预措施
Group 1(N=10)
Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment A (Drug)
Group 1(N=10)
Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment B (Drug)
Group 1(N=10)
Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment C (Drug)
Group 3(N=10)
Treatment A for Period I Treatment E Treatment D
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment E (Drug)
Group 2(N=10)
Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment A (Drug)
Group 2(N=10)
Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment B (Drug)
Group 2(N=10)
Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment C (Drug)
Group 3(N=10)
Treatment A for Period I Treatment E Treatment D
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment A (Drug)
Group 3(N=10)
Treatment A for Period I Treatment E Treatment D
*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
干预措施: Treatment D (Drug)
Group 4(N=10)
Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment A (Drug)
Group 4(N=10)
Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment D (Drug)
Group 4(N=10)
Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3
*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
干预措施: Treatment E (Drug)
结局指标
主要结局
AUCτ,ss
时间窗: up to 12hour(or 24hour) after administration
AUCτ,ss of each drug
Cmax,ss
时间窗: up to 12hour(or 24hour) after administration
Cmax,ss of each drug
次要结局
- Vdss/F(up to 12hour(or 24hour) after administration)
- Tmax,ss(up to 12hour(or 24hour) after administration)
- Cmin,ss(up to 12hour(or 24hour) after administration)
- CLss/F(up to 12hour(or 24hour) after administration)
- fluctuation(up to 12hour(or 24hour) after administration)