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

Phase 1

Completed

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

• Registration Number: NCT00808678
• 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 Start: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-16
• Primary Completion: 2009-01
• 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
1	ABT-143	ABT-143 capsules 20/135 mg
2	ABT-335	ABT-335 135 mg and rosuvastatin 20 mg
2	rosuvastatin	ABT-335 135 mg and rosuvastatin 20 mg

Primary Outcome Measures

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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 14762; 🇺🇸 Orlando, Florida, United States