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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681525
First Posted: May 21, 2008
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • PK interaction [ Time Frame: Study duration approximately 62 days ]

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 Name: fenofibric acid
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
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 Name: fenofibric acid
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

  Eligibility

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
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
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): NCT00681525


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

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00681525     History of Changes
Other Study ID Numbers: M10-367
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: October 19, 2010
Last Verified: September 2010

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