Assessment of the Effect of Food on ABT-143 Bioavailability

This study is currently recruiting participants.

Verified by Abbott, July 2008

Sponsors and Collaborators:	Abbott 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

MedlinePlus related topics: Calcium

Drug Information available for: Rosuvastatin Rosuvastatin calcium Calcium gluconate

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	114
Study Start Date:	July 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Eilis Purcell

847-938-3883

eilis.purcell@abbott.com

Locations

United States, Indiana
	Recruiting
Evansville, Indiana, United States, 47714

Sponsors and Collaborators

Abbott

AstraZeneca

Investigators

Study Director:

Dawn M. Carlson, MD, MPH

Abbott

More Information

Responsible Party:	Abbott ( Dawn Carlson, MD, MPH )
Study ID Numbers:	M10-442
Study First Received:	July 18, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00719693
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Food effect, phase I
adverse events

Study placed in the following topic categories:

Calcium, Dietary
Rosuvastatin
Fenofibric acid
Procetofen

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009