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A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00681525
First received: May 19, 2008
Last updated: October 18, 2010
Last verified: September 2010
History of Changes
  Purpose

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.


Condition Intervention Phase
Pharmacokinetics
 Drug: ABT-335
Drug: Atorvastatin
Drug: Ezetimibe
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • PK interaction [ Time Frame: Study duration approximately 62 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: April 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT-335 135 mg
 Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
  • ABT-335
Experimental: B
Atorvastatin 80 mg and Ezetimibe 10 mg
 Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Name: atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days
Other Name: ezetimibe
Experimental: C
ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg
 Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
  • ABT-335
Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Name: atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days
Other Name: ezetimibe

  Eligibility

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

Inclusion Criteria:

  • Healthy male or female subjects

Exclusion Criteria:

  • Clinically significant diseases or disorders
  • Positive screens for drug and alcohol
  • Pregnant or breast-feeding females
  • Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681525

Locations
United States, Florida
Site Reference ID/Investigator# 8087
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00681525     History of Changes
Other Study ID Numbers: M10-367
Study First Received: May 19, 2008
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fenofibric acid
Atorvastatin
Ezetimibe
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 16, 2013