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Assessment of the Effect of Food on ABT-143 Bioavailability

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 18, 2008
Last updated: September 27, 2012
Last verified: September 2012
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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 30 days ]

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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00719693

United States, Indiana
Site Reference ID/Investigator# 9242
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT00719693     History of Changes
Other Study ID Numbers: M10-442
Study First Received: July 18, 2008
Last Updated: September 27, 2012

Keywords provided by AstraZeneca:
Food effect, phase I
adverse events

Additional relevant MeSH terms:
Calcium, Dietary
Rosuvastatin Calcium
Fenofibric acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on August 21, 2017