NCT01394653已完成1 期
Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -
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
- 36
- 主要终点
- Area under the curve of YM060 plasma concentration -time curve
研究概览
简要总结
A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy assessed by the principal investigator or sub-investigators
- •non-smoking or stop smoking at least 90 days before the study
- •body weight: over 50.0kg and less than 80.0kg
- •body mass index (BMI): over 17.6 and less than 26.4
排除标准
- •participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
- •donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
- •received any drugs within 7 days before the study or going to receive any drugs
- •deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
- •deviance from normal range in lab-tests
- •history of drug allergy
- •history or current diagnosis of stomach, small intestine or large intestine diseases
- •history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- •history or current diagnosis of colitis ischemic
- •history or current diagnosis of hepatic diseases
- •history or current diagnosis of cardiovascular diseases
- •history or current diagnosis of respiratory diseases
- •history or current diagnosis of malignant tumor
- •received ramosetron tablet
研究组 & 干预措施
orally-disintegrating (OD) tablet precedence group
Experimental
干预措施: YM060 (Drug)
conventional tablet precedence group
Experimental
干预措施: YM060 (Drug)
结局指标
主要结局
Area under the curve of YM060 plasma concentration -time curve
时间窗: up to 24 hours after administration
Maximal concentration of YM060 plasma concentration
时间窗: up to 24 hours after administration
次要结局
- Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG(up to 24 hours after administration)
研究者
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