An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.
详细描述
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- •The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit
排除标准
- •Patients with Medical history increasing the risk of bleeding
研究组 & 干预措施
Arm A-Rivaroxaban
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
干预措施: Rivaroxaban 18mg Oral Tablet (Drug)
Arm A-Rivaroxaban
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
干预措施: Rivaroxaban 20 MG Oral Tablet (Drug)
Arm B-Rivaroxaban
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
干预措施: Rivaroxaban 18mg Oral Tablet (Drug)
Arm B-Rivaroxaban
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
干预措施: Rivaroxaban 20 MG Oral Tablet (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: pre-dose to 34 hours
Cmax of Rivaroxaban
Area Under the Curve in time plot (AUCt)
时间窗: pre-dose to 34 hours
AUCt of Rivaroxaban
次要结局
未报告次要终点