NCT01258452已完成1 期
Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CERESPIR
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- peak CHF 5074 plasma concentration (Cmax)
研究概览
简要总结
To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
- •Subject has a body mass index between 18 and 30 kg/m^2, inclusive.
排除标准
- •Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- •Abnormal result of liver function tests, renal function tests or thyroid tests performed at screening.
- •Significant allergic conditions that require medical treatment
- •Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- •Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
研究组 & 干预措施
CHF 5074 (fed group)
Experimental
oral tablet, single dose
干预措施: CHF 5974 (Drug)
CHF 5074 (fasting group)
Experimental
oral tablet, single dose
干预措施: CHF 5074 (Drug)
结局指标
主要结局
peak CHF 5074 plasma concentration (Cmax)
时间窗: from Day 1 to Day 5
area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)
时间窗: from Day 1 to Day 5
次要结局
- the time of occurrence of Cmax (Tmax)(from Day 1 to Day 5)
研究者
研究点 (1)
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