NCT00839293已完成1 期
Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage
研究概览
简要总结
The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A condition of general good health
- •BMI 18 to 29
排除标准
- •Currently enrolled in another clinical study
- •Females who are pregnant or breast-feeding
研究组 & 干预措施
A
Experimental
ABT -335 capsules 135mg
干预措施: ABT-335 (Drug)
B
Experimental
ABT-335 capsules 45mg
干预措施: ABT-335 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage
时间窗: 14 Days
To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose
时间窗: 14 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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