Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- AUC
研究概览
简要总结
The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.
详细描述
This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.
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
- 18 Years 至 40 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 clinicallyimportant 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
800-mg group
Ten healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state.
干预措施: rufinamide (Drug)
200-mg group
Ten healthy subjects were administered a single oral dose of 200 mg rufinamide tablets in fasted and fed state at day 1 and then received repeated oral doses of rufinamide (200 mg) once daily for 6 days.
干预措施: rufinamide (Drug)
400-mg group
Ten healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state.
干预措施: rufinamide (Drug)
1200-mg group
Ten healthy subjects were administered a single oral dose of 1200 mg rufinamide tablets in fasted state.
干预措施: rufinamide (Drug)
结局指标
主要结局
AUC
时间窗: three days
the area under the concentration-time curve
次要结局
未报告次要终点
研究者
Weiyong Li
Institute of Clinical Pharmacy
Wuhan Union Hospital, China