NCT01720212已完成1 期
An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- AUC of YM178 assessed by the plasma concentration changes
研究概览
简要总结
To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
- •Good health status
- •The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.
排除标准
- •The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
- •Drug abusers and alcoholics.
- •The subject who has consumed alcohol within 36 hours before administration.
- •The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
- •The subject who is positive for human immunodeficiency virus (HIV).
- •The subject who consumes more than 1L tea and coffee per day.
- •The subject who has donated or lost over 200 mL blood
- •The subject who has participated in other clinical trials
- •The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
- •The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
- •Psychopath.
研究组 & 干预措施
Single dose group
Experimental
干预措施: YM178 (Drug)
Multiple dose group
Experimental
干预措施: YM178 (Drug)
结局指标
主要结局
AUC of YM178 assessed by the plasma concentration changes
时间窗: Up to 96 hours after administration
Cmax of YM178 assessed by the plasma concentration changes
时间窗: Up to 96 hours after administration
t1/2 of YM178 assessed by the plasma concentration changes
时间窗: Up to 96 hours after administration
次要结局
- Safety assessment of YM178(Up to 33 days)
研究者
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