Sustained Release Oral Formulation For Treatment Of Parkinsons Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Blood CD Level - Minute 15
研究概览
简要总结
LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is 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. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.
详细描述
This is a randomized, double-blind (dose-masked), single-dose crossover study to investigate the pharmacokinetics of a novel delivery method and formulation of different doses of CD/LD in normal volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •Adult healthy male or female
- •Age 18 to 65 years
- •Willingness and ability to complete study procedures
排除标准
- •medical conditions that require taking medications regularly.
研究组 & 干预措施
Formulation A
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
干预措施: Formulation A (Drug)
Formulation B
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
干预措施: Formulation B (Drug)
Formulation C
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
干预措施: Formulation C (Drug)
结局指标
主要结局
Blood CD Level - Minute 15
时间窗: Minute 15 after administration
Measured in \[ng/mL\]
Blood LD Level - Minute 15
时间窗: Minute 15 after administration
Measured in \[ng/mL\]
Blood CD Level - Minute 30
时间窗: Minute 30 after administration
Measured in \[ng/mL\]
Blood LD Level - Minute 30
时间窗: Minute 30 after administration
Measured in \[ng/mL\]
Blood CD Level - Minute 45
时间窗: Minute 45 after administration
Measured in \[ng/mL\]
Blood LD Level - Minute 45
时间窗: Minute 45 after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 1
时间窗: One hour after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 1
时间窗: One hour after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 2
时间窗: Two hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 2
时间窗: Two hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 3
时间窗: Three hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 3
时间窗: Three hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 4
时间窗: Four hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 4
时间窗: Four hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 5
时间窗: Five hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 5
时间窗: Five hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 6
时间窗: Six hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 6
时间窗: Six hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 7
时间窗: Seven hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 7
时间窗: Seven hours after administration
Measured in \[ng/mL\]
Blood CD Level - Hour 8
时间窗: Eight hours after administration
Measured in \[ng/mL\]
Blood LD Level - Hour 8
时间窗: Eight hours after administration
Measured in \[ng/mL\]
次要结局
未报告次要终点