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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 21, 2008
Last updated: September 27, 2012
Last verified: September 2012

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
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:

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00826358

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

No publications provided

Responsible Party: AstraZeneca 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

Additional relevant MeSH terms:
Fenofibric acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 17, 2014