Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters, pharmacodynamic variables
研究概览
简要总结
This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) is 19 to 29, inclusive.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- •Written informed consent prior to the initiation of screening or study-specific procedures.
排除标准
- •Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
- •Subjects taking concomitant medications.
- •Subjects with a recent history of surgery or trauma.
- •Subjects with a history of any bleeding disorder.
研究组 & 干预措施
Warfarin
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
干预措施: Warfarin (Drug)
Warfarin plus ABT-335 plus Rosuvastatin
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
干预措施: warfarin plus ABT-335 plus rosuvastatin 5 mg (Drug)
Warfarin plus ABT-335 mg plus rosuvastatin 20 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
干预措施: warfarin plus ABT-335 plus rosuvastatin 20 mg (Drug)
结局指标
主要结局
Pharmacokinetic parameters, pharmacodynamic variables
时间窗: Day 24
次要结局
- Vital signs, physical examinations, laboratory tests, ECGs, adverse events(Day 29)