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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
  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
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 ]
  • To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ]

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.
Active Comparator: B
ABT-335 45mg and rosuvastatin 5mg
Drug: ABT-335
Once, see Arm Description for more detail
Drug: rosuvastatin
once, see Arm Description for more detail

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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 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

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

Keywords provided by AstraZeneca:
Adverse events
Pharmacokinetic

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

ClinicalTrials.gov processed this record on June 27, 2017