NCT00808678已完成1 期
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium
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
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults
研究概览
简要总结
The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
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 19 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
1
Experimental
ABT-143 capsules 20/135 mg
干预措施: ABT-143 (Drug)
2
Active Comparator
ABT-335 135 mg and rosuvastatin 20 mg
干预措施: ABT-335 (Drug)
2
Active Comparator
ABT-335 135 mg and rosuvastatin 20 mg
干预措施: rosuvastatin (Drug)
结局指标
主要结局
To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults
时间窗: 7 days
To determine the safety and tolerability of ABT-143 vs (ABT-335 + rosuvastatin) in healthy adults
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mgHealthyNCT00826358AstraZeneca90
已完成
1 期
Comparison of Fenofibric Acid Bioavailability From ABT-335 CapsulesHealthyNCT00839293Abbott32
已完成
Unknown
Bioequivalence of FenofibrateIRCT20221002056075N2Aani ?Darman Pharmaceutical Company24
已完成
不适用
Bioequivalence Study of Furosemide 80mg Tablets Under Fasting ConditionsHealthyNCT00778180Ranbaxy Laboratories Limited44
已完成
1 期
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.AsthmaNCT01494610GlaxoSmithKline60