Assessment of the Effect of Food on ABT-143 Bioavailability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00719693
First received: July 18, 2008
Last updated: September 27, 2012
Last verified: September 2012
  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 1

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:


Further study details as provided by AstraZeneca:

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
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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
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00719693     History of Changes
Other Study ID Numbers: M10-442
Study First Received: July 18, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Calcium, Dietary
Fenofibrate
Fenofibric acid
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Bone Density Conservation Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014