A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
研究概览
简要总结
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.
详细描述
The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
- •FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
- •Body Mass Index (BMI) between 18 - 30 kg/m2
排除标准
- •No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- •Negative drug and alcohol testing;
- •Negative pregnancy test for female subjects
研究组 & 干预措施
CVT-301
CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
Sinemet® (carbidopa/levodopa)
干预措施: CVT-301 (Dose Level 1) (Drug)
CVT-301
CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
Sinemet® (carbidopa/levodopa)
干预措施: CVT-301 (Dose Level 2) (Drug)
CVT-301
CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
Sinemet® (carbidopa/levodopa)
干预措施: Sinemet® (Drug)
结局指标
主要结局
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
时间窗: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Maximum observed plasma drug concentration (Cmax)
时间窗: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
次要结局
- Number of subjects with Adverse Events (AEs) including Serious AEs(up to 9 days)