An Open-Label, Multiple-Dose Study of MCS-2 to Examine the Pharmacokinetics of MCS and Other Components After Once-daily Oral Dosing in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 主要终点
- Serum MCS and other components levels
研究概览
简要总结
This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.
详细描述
This study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of MCS and other components after once-daily oral dosing for 21 days.
Subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. During the treatment phase, subjects will receive MCS, once-daily within one hour after the evening meal. After completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. Throughout each of these phases, blood samples will be collected and assayed for concentrations of MCS and other components. The duration of protocol participation is expected to be 77 days for each eligible subject who completes the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteers
- •18 years of age or older
排除标准
- •Subjects who can not comply with the study procedures or sign the informed consent form
研究组 & 干预措施
MCS-2
干预措施: MCS-2 soft-gel capsule (Drug)
结局指标
主要结局
Serum MCS and other components levels
时间窗: 21 days
次要结局
- Incidence of treatment-emergent adverse events(21 days)
