临床试验/NCT00826358

NCT00826358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 mg

AstraZeneca1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2008年11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: 90
试验地点: 1
主要终点: To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

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

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

B

Active Comparator

ABT-335 45mg and rosuvastatin 5mg

干预措施: rosuvastatin (Drug)

A

Experimental

ABT-143 capsules 5/45mg

干预措施: ABT-143 (Drug)

B

Active Comparator

ABT-335 45mg and rosuvastatin 5mg

干预措施: ABT-335 (Drug)

结局指标

主要结局

To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

时间窗: 7 days

To determine the pharmacokinetic profile for 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

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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