A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.
详细描述
Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
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 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
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment A_Period 1 (Drug)
Group 1
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment B_Period 2 (Drug)
Group 1
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment A_Period 3 (Drug)
Group 1
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment B_Period 4 (Drug)
Group 2
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment B_Period 1 (Drug)
Group 2
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment A_Period 2 (Drug)
Group 2
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment B_Period 3 (Drug)
Group 2
- Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Treatment B: Administration alone of 1 tablet of JW0105
干预措施: Treatment A_Period 4 (Drug)
结局指标
主要结局
AUCt
时间窗: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
Cmax
时间窗: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
次要结局
未报告次要终点