NCT01340248已完成1 期
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration 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
- evaluation of pharmacokinetics
研究概览
简要总结
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in 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
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 50 aged in healthy adults
- •Weight more than 55kg, IBW 20% within the range
- •Agreement with written informed consent
排除标准
- •Subject has hypersensitivity reaction or clinically significant history about investigational drug
- •Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
- •Inadequate result of laboratory test
- •AST(SGOT) or ALT(SGPT) > 1.5 x upper limit of normal range
- •Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- •Creatinine clearance < 80ml/min
- •Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug
- •Subject takes an abnormal meal which affect the ADME of drug
- •Previously participated in other trial within 90 days
- •Previously make whole blood donation within 60 days or component blood donation within 30 days
- •Subject with positive reaction for reason of laboratory test result
- •An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
研究组 & 干预措施
Dilatrend 64mg capsule
Experimental
* Randomized, open-label, single dose, two-period, two-way, crossover study
- group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
- group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting
干预措施: Dilatrend 64mg capsule (Drug)
结局指标
主要结局
evaluation of pharmacokinetics
时间窗: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
次要结局
- evaluation of safety(from screenig to post-study visit)
研究者
研究点 (1)
Loading locations...
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