Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Cmax
研究概览
简要总结
This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.
详细描述
The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index between19 and 24 kg/m2
- •negative for HIV and hepatitis B
- •had no clinical important findings on health tests
- •thorax radiography and ECG with no abnormalities
- •normal blood pressure values
- •heart rate
排除标准
- •any drug treatment within 2 weeks before starting the study
- •participation in another clinical study within the previous 3 months
- •alcoholism and smoking
- •pregnancy
- •breast-feeding
- •hypocalcemia
- •blood donation or participation in other clinical trials within 3 months before enrollment in the study
- •sitting blood pressure <80/50 mm Hg or >140/100 mm Hg
- •A ventricular rate <60 beats/min or >100 beats/min at rest
研究组 & 干预措施
10-mg group
Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state.
干预措施: lafutidine (Drug)
20-mg group
Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state.
干预措施: lafutidine (Drug)
40-mg group
Twelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state.
干预措施: lafutidine (Drug)
结局指标
主要结局
Cmax
时间窗: one day
Peak concentration
Area under the curve
时间窗: one day
Area under the curve - plasma concentration
Clearance
时间窗: one day
Clearance
Apparent volume of distribution-V
时间窗: one day
The apparent volume of distribution
次要结局
- Safety (adverse events)(six weeks)
研究者
Weiyong Li
vice director of the pharmcy department
Wuhan Union Hospital, China