Sustained Release Oral Formulation for Treatment of Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Carbidopa/levodopa serum level Efficacy of the delivery method
研究概览
简要总结
Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
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
- •Normal healthy
- •Are 18-65 years of age
- •Are not currently taking medications regularly
- •Able to fast 6 hours (water allowed)
排除标准
- •Pregnancy
- •Inability to fast
研究组 & 干预措施
levodopa/carbidopa oral formulation A
LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.
干预措施: levodopa/carbidopa oral formulation A (Drug)
levodopa/carbidopa oral formulation B
LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.
干预措施: levodopa/carbidopa oral formulation B (Drug)
结局指标
主要结局
Carbidopa/levodopa serum level Efficacy of the delivery method
时间窗: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)
Carbidopa/levodopa serum level
次要结局
未报告次要终点