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Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium

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ClinicalTrials.gov Identifier: NCT00808678
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: ABT-143 Drug: ABT-335 Drug: rosuvastatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2008
Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
ABT-143 capsules 20/135 mg
Drug: ABT-143
once, see arm description for more information
Active Comparator: 2
ABT-335 135 mg and rosuvastatin 20 mg
Drug: ABT-335
once, see arm description for more information
Drug: rosuvastatin
once, see arm description for more detail

Primary Outcome Measures :
  1. To determine the safety and tolerability of ABT-143 vs (ABT-335 + rosuvastatin) in healthy adults [ Time Frame: 7 days ]
  2. To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults [ Time Frame: 7 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. A condition of general good health
  2. BMI 19 to 29

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808678

United States, Florida
Site Reference ID/Investigator# 14762
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Study Director: Torbjörn Lundström, MD AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00808678     History of Changes
Other Study ID Numbers: M10-662
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by AstraZeneca:
Adverse Events

Additional relevant MeSH terms:
Rosuvastatin Calcium
Fenofibric acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors