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临床试验/NCT01003171
NCT01003171Unknown1 期

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

Health Ever Bio-Tech Co., Ltd.0 个研究点目标入组 12 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Industry

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