An Open-Label, Randomized, Single Dose Study to Evaluate the Pharmacokinetics of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Subjects
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
- AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
研究概览
简要总结
To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria to be included in this study:
- •Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline
- •Subjects who contravene the restrictions on concomitant medications, food and beverages
- •Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent
研究组 & 干预措施
Cohort 1: E0302 Sustained Release (SR1) 1500 mcg
Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.
干预措施: E0302 SR1 (Drug)
Cohort 2: E0302 Sustained Release (SR3) 1500 mcg
Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
干预措施: E0302 SR3 (Drug)
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg
Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
干预措施: E0302 SR2 (Drug)
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg
Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
干预措施: E0302 IR (Drug)
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg
Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
干预措施: E0302 SR2 (Drug)
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg
Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
干预措施: E0302 IR (Drug)
结局指标
主要结局
AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
时间窗: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration
时间窗: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
时间窗: Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
Number of Participants With Abnormal 12-lead Electrocardiogram Values
时间窗: Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
时间窗: Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
Number of Participants With Abnormal Vital Sign Values
时间窗: Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Number of Participants With Abnormal Clinical Laboratory Values
时间窗: Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
次要结局
未报告次要终点