NCT01723891已完成1 期
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male 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
- 24
- 试验地点
- 1
- 主要终点
- AUCt, Cmax
研究概览
简要总结
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
- •Volunteers without apriority of chronic disease
- •Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
- •Volunteers who comply with the protocol, understand and sign an informed consent
排除标准
- •Sensitive response to acebrophylline and xanthine
- •Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
- •Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
- •Known history of gastrointestinal disease which affects the absorption of medicine.
- •Excluded by screening tests
- •Upper limit of AST, ALT>1.25 times Upper limit of total bilirubin>1.5 times
- •Estimated GFR<80mL/min/1.73m2)
- •systolic blood pressure < 90 or > 150, diastolic blood pressure <50 or >100
- •Known history of drug abuse
- •caffeine>5cups/day, alcohol>210g/week, 10 more cigarettes/day
- •Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
- •Participation in any clinical investigation within 60 days prior to study start
- •Donation of blood within 60 days, donation of component blood within 30days
- •Judged by the investigators to be undesirable as subjects
研究组 & 干预措施
Surfolase capsule & HT-002-01
Active Comparator
干预措施: Surfolase capsule (Drug)
Surfolase capsule & HT-002-01
Active Comparator
干预措施: HT-002-01 (Drug)
HT-002-01 & Surfolase capsule
Active Comparator
干预措施: Surfolase capsule (Drug)
HT-002-01 & Surfolase capsule
Active Comparator
干预措施: HT-002-01 (Drug)
结局指标
主要结局
AUCt, Cmax
次要结局
- AUCinf, Tmax, t1/2
研究者
研究点 (1)
Loading locations...
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