NCT00501267已完成1 期
A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Absorption rate of solabegron and oxybutynin
研究概览
简要总结
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males & females ages 18-65;
- •Body weight >50kg; BMI between 19-32;
- •Signed and dated informed consent; QTc Interval <450 msec;
排除标准
- •Resting blood pressure >140/90 mmHg or HR >100 at screening;
- •History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
- •Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
- •Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
- •history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
- •history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
- •clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
结局指标
主要结局
Absorption rate of solabegron and oxybutynin
时间窗: as measured by multiple blood draws after repeat dosing
次要结局
- To assess bladder function(prior to dosing Session 1 and post dose for each session)
研究者
研究点 (2)
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