A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0101 and C2101 and Administration of JW0102 in Healthy Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 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 JW0101 and C2101 and administration of JW0102 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.
Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.
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
Sequence A
Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102
Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
干预措施: Reference Drug or Test Drug (Drug)
Sequence B
Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102
Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
干预措施: Reference Drug or Test Drug (Drug)
结局指标
主要结局
AUCt
时间窗: Day1 0h ~ Day4 72h
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Cmax
时间窗: Day1 0h ~ Day4 72h
Describes the blood concentration statistically by pharmacokinetic blood
次要结局
未报告次要终点