An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Area Under the Curve in time plot (AUCt)
研究概览
简要总结
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.
详细描述
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B 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
- All
- 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 volunteers at the time of screening visit
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Sequence A
Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
干预措施: AD-221 (Drug)
Sequence A
Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
干预措施: AD-221A and AD-221B (Drug)
Sequence B
Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
干预措施: AD-221 (Drug)
Sequence B
Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
干预措施: AD-221A and AD-221B (Drug)
结局指标
主要结局
Area Under the Curve in time plot (AUCt)
时间窗: pre-dose to 72 hours
AUCt of AD-221
Peak Plasma Concentration (Cmax)
时间窗: pre-dose to 72 hours
Cmax of AD-221
次要结局
未报告次要终点