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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00826358

Enrollment

Registered

2009-01-22

Start date

2008-11-30

Completion date

Unknown

Last updated

2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Adverse events, Pharmacokinetic

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.

Interventions

DRUGABT-143

Once, please see Arm Description for more details.

DRUGABT-335

Once, see Arm Description for more detail

DRUGrosuvastatin

once, see Arm Description for more detail

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026