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Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00826358
First received: October 21, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: ABT-143
Drug: ABT-335
Drug: rosuvastatin
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT-143 capsules 5/45mg
 Drug: ABT-143
Once, please see Arm Description for more details.
Other Name: ABT-143
Active Comparator: B
ABT-335 45mg and rosuvastatin 5mg
 Drug: ABT-335
Once, see Arm Description for more detail
Other Name: ABT-335
Drug: rosuvastatin
once, see Arm Description for more detail
Other Name: rosuvastatin

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826358

Locations
United States, Florida
Site Reference ID/Investigator# 13441
Orlando, Florida, United States, 32809
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00826358     History of Changes
Other Study ID Numbers: M10-535
Study First Received: October 21, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Adverse events
Pharmacokinetic

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

ClinicalTrials.gov processed this record on May 23, 2013