Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular and Intravenous Administration of Levosulpiride After Single and Multiple Doses in Fasting Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Apparent volume of distribution-V
研究概览
简要总结
The aim of this study was to characterise the pharmacokinetic properties and assess the safety of different formulations of levosulpiride in healthy Chinese volunteers.
详细描述
Levosulpiride was administered to 42 healthy male and female (1:1) subjects as tablet (orally) and injection (intramuscularly and intravenously) formulations. Blood samples were collected at regular intervals after single and multiple drug administration. The concentration of levosulpiride in plasma was determined using a validated high performance liquid chromatography-tandem mass spectrometry method. Non-compartmental analysis was performed to estimate pharmacokinetic parameters. The analysis of variance was used to test for linearity and assess the effect of gender on the pharmacokinetic properties of the study drug. Adverse effects were monitored using investigators' questionnaires and subjects' spontaneous reports, vital sign measurements, hematology, clinical chemistry, and electrocardiogram.
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 45 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
part 1
12 subjects successively received a single dose of levosulpiride tablets 25, 50, or 100 mg via oral administration and 50-mg of levosulpiride tablets 3 times a day for 7 days.
干预措施: Levosulpiride (Drug)
part 2
30 subjects were randomly assigned to 1 of 3 treatment groups (25, 50, or 75 mg) via i.m. administration, the 50-mg group subjects also received levosulpiride by i.v. route and repeated administration by i.m. route (twice a day for 3 days).
干预措施: Levosulpiride (Drug)
结局指标
主要结局
Apparent volume of distribution-V
时间窗: two days
The apparent volume of distribution
Area under the curve-AUC
时间窗: two days
Area under the curve - plasma concentration
Cmax
时间窗: two days
Peak concentration
Clearance-CL
时间窗: two days
Clearance
次要结局
- Safety (adverse events)(one month)
研究者
Weiyong Li
vice director of the pharmacy department
Wuhan Union Hospital, China