Assessment of the Effect of Food on ABT-143 Bioavailability

This study has been completed.

First Received on July 18, 2008. Last Updated on October 18, 2010 History of Changes

Sponsor:	Abbott
Collaborator:	AstraZeneca
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00719693

Purpose

Single-dose, open-label, two-period crossover study of ABT-143

Condition	Intervention	Phase
Pharmacokinetic Variables	Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid ) Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Calcium

Drug Information available for: Rosuvastatin calcium Rosuvastatin Calcium gluconate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	115
Study Start Date:	July 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A ABT-143 under low-fat meal condition	Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid ) one dose under low-fat meal condition Other Names: ABT-143 fenofibric acid/rosuvastatin calcium
Experimental: B ABT-143 under fasting meal condition	Drug: ABT-143 (rosuvastatin calcium and fenofibric acid ) one dose under fasting meal condition

Eligibility

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

Criteria

Inclusion Criteria:

18-55 years of age (inclusive)
BMI 19 to 29 inclusive

Exclusion Criteria:

Asian ancestry
Concurrent participation in another study
Females pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719693

Locations

United States, Indiana
Site Reference ID/Investigator# 9242
Evansville, Indiana, United States, 47710

Sponsors and Collaborators

Abbott

AstraZeneca

Investigators

Study Director:

Dawn M. Carlson, MD, MPH

Abbott

More Information

No publications provided

Responsible Party:	Dawn Carlson, MD, MPH, Abbott
ClinicalTrials.gov Identifier:	NCT00719693 History of Changes
Other Study ID Numbers:	M10-442
Study First Received:	July 18, 2008
Last Updated:	October 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Food effect, phase I
adverse events

Additional relevant MeSH terms:

Calcium, Dietary
Fenofibric acid
Rosuvastatin
Fenofibrate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012