NCT03712241已完成1 期
A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 BMI of 18 to 30 kg/m2, inclusive.
- •Subject meets all inclusion criteria outlined in the clinical study protocol.
排除标准
- •Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
- •Subject has a supine blood pressure 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 50 mm Hg diastolic at Screening or Admission (Day -1).
- •Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
- •Subject does not meet any exclusion criteria outlined in the clinical study protocol.
研究组 & 干预措施
Treatment A
Experimental
K-285 dose/application method A
干预措施: K-285 (Drug)
Treatment B
Experimental
K-285 dose/application method B
干预措施: K-285 (Drug)
Treatment C
Experimental
K-285 dose/application method C
干预措施: K-285 (Drug)
Treatment D
Active Comparator
Indomethacin capsule
干预措施: Indomethacin (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Area under the plasma versus concentration time curve (AUC)
时间窗: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
次要结局
- Number of participants with treatment-related adverse events(Through study completion approximately 33 to 38 days)
研究者
研究点 (1)
Loading locations...
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