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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-143; Drug: ABT-335; Drug: rosuvastatin

• Registration Number: NCT00826358
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-21
• Study Start: 2008-11
• Primary Completion: 2008-11
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. A condition of general good health
2. BMI 19 to 29

Exclusion Criteria

1. Currently enrolled in another clinical study
2. Females who are pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	ABT-143	ABT-143 capsules 5/45mg
B	ABT-335	ABT-335 45mg and rosuvastatin 5mg
B	rosuvastatin	ABT-335 45mg and rosuvastatin 5mg

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.	7 days
To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.	7 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 13441; 🇺🇸 Orlando, Florida, United States