临床试验/NCT00681395

NCT00681395已完成1 期

Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

AstraZeneca1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2008年5月最近更新: 2012年9月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 64
试验地点: 1
主要终点: Adverse event and safety laboratory assessments

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate 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

•General good health
•BMI 19 to 29

排除标准

•Currently enrolled in another study
•Females who are pregnant or breastfeeding

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 135mg and rosuvastatin 20mg

干预措施: ABT-335 (Drug)

2

Active Comparator

ABT-335 135mg and rosuvastatin 20mg

干预措施: Rosuvastatin (Drug)

3

Experimental

ABT-143 capsules 5/45mg

干预措施: ABT-143 (Drug)

4

Active Comparator

ABT-335 45mg and rosuvastatin 5mg

干预措施: ABT-335 (Drug)

4

Active Comparator

ABT-335 45mg and rosuvastatin 5mg

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

Adverse event and safety laboratory assessments

时间窗: 7 days

Pharmacokinetic parameters

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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