An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- gabapentin concentrations in blood
研究概览
简要总结
The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
详细描述
This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, male and female subjects aged between 18 and 65 years old.
- •normal body weight.
- •normal ECG, vital signs and lab tests.
- •normal kidney function
- •agree to use acceptable contraceptive methods required.
- •capable of giving written informed consent.
排除标准
- •positive blood alcohol or urine drug test.
- •positive hepatitis B/C and HIV
- •donation of more than 450 mL blood within the 56 days.
- •sensitivity to gabapentin
- •pregnant or lactating females
- •certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
- •history of seizure
研究组 & 干预措施
GSK1838262 arm
Each subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence.
干预措施: open label (Drug)
结局指标
主要结局
gabapentin concentrations in blood
时间窗: measured up to 36 hr after dosing
次要结局
- gabapentin concentrations in urine(measured up to 36 hr after dosing)
- Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.(throughout the study)