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

This study has been completed.

First Received: October 21, 2008 Last Updated: January 27, 2009 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00826358

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: ABT-143 Drug: ABT-335 Drug: rosuvastatin	Phase I

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study

Further study details as provided by Abbott:

Primary Outcome Measures:

To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental ABT-143 capsules 5/45mg	Drug: ABT-143 Once, please see Arm Description for more details.
B: Active Comparator ABT-335 45mg and rosuvastatin 5mg	Drug: ABT-335 Once, see Arm Description for more detail Drug: rosuvastatin once, see Arm Description for more detail

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A condition of general good health
BMI 19 to 29

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826358

Locations

United States, Florida

Orlando, Florida, United States, 32809

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Laura Williams, MD, MPH, Global Project Head )
Study ID Numbers:	M10-535
Study First Received:	October 21, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00826358 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Adverse events
Pharmacokinetic

Study placed in the following topic categories:

Antimetabolites
Calcium, Dietary
Rosuvastatin
Fenofibric acid

Antilipemic Agents
Anticholesteremic Agents
Healthy
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Rosuvastatin
Molecular Mechanisms of Pharmacological Action
Fenofibric acid
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009