NCT00488098已完成1 期
An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
研究概览
简要总结
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males/Females aged 18-45 years
- •Non-smokers
- •BMI 19-30 kg.m2
- •QTc<450msec
排除标准
- •Use of oral contraception
- •Positive breath alcohol and drug screen
- •Regular alcohol consumption
- •Current psychiatric illness or within 1 year.
- •History of GI, hepatic or renal disease
- •Uncontrolled hypertension
结局指标
主要结局
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
时间窗: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
次要结局
- Adverse events(all visits)
- vitals (all visits) + ECG(at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.)
- labs(at screening and 2 weeks post dose)
研究者
研究点 (2)
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