Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Measured Plasma Concentration (Cmax)
研究概览
简要总结
A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent before any study-specific evaluation is performed.
- •Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
- •Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- •Subject meets all inclusion criteria outlined in the clinical study protocol.
排除标准
- •Subject has clinically relevant abnormalities in the screening or check-in assessments.
- •Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- •Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- •Subject does not meet any exclusion criteria outlined in the clinical study protocol.
研究组 & 干预措施
Treatment A
K-877 CR Tablet A
干预措施: K-877 CR Tablet E (Drug)
Treatment A
K-877 CR Tablet A
干预措施: K-877 CR Tablet A (Drug)
Treatment A
K-877 CR Tablet A
干预措施: K-877 CR Tablet B (Drug)
Treatment A
K-877 CR Tablet A
干预措施: K-877 IR Tablet (Drug)
Treatment B
K-877 CR Tablet B
干预措施: K-877 CR Tablet A (Drug)
Treatment B
K-877 CR Tablet B
干预措施: K-877 CR Tablet B (Drug)
Treatment B
K-877 CR Tablet B
干预措施: K-877 CR Tablet E (Drug)
Treatment B
K-877 CR Tablet B
干预措施: K-877 IR Tablet (Drug)
Treatment C
K-877 CR Tablet E
干预措施: K-877 CR Tablet A (Drug)
Treatment C
K-877 CR Tablet E
干预措施: K-877 CR Tablet B (Drug)
Treatment C
K-877 CR Tablet E
干预措施: K-877 CR Tablet E (Drug)
Treatment C
K-877 CR Tablet E
干预措施: K-877 IR Tablet (Drug)
Treatment D
K-877 IR Tablet
干预措施: K-877 CR Tablet A (Drug)
Treatment D
K-877 IR Tablet
干预措施: K-877 CR Tablet B (Drug)
Treatment D
K-877 IR Tablet
干预措施: K-877 CR Tablet E (Drug)
Treatment D
K-877 IR Tablet
干预措施: K-877 IR Tablet (Drug)
结局指标
主要结局
Maximum Measured Plasma Concentration (Cmax)
时间窗: Up to 24 hours after single administration
Area Under the Plasma Concentration Versus Time Curve (AUC)
时间窗: Up to 24 hours after single administration
次要结局
- Treatment emergent adverse events summarized by treatment(Up to 16 days after administration)