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Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00839293
First received: February 6, 2009
Last updated: October 14, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.


Condition Intervention Phase
Healthy
 Drug: ABT-335
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: February 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT -335 capsules 135mg
 Drug: ABT-335
Once, see arm description for more information
Other Names:
  • ABT-335
  • fenofibric acid
  • Trilipix
Experimental: B
ABT-335 capsules 45mg
 Drug: ABT-335
Once, see arm description for more information
Other Names:
  • ABT-335
  • fenofibric acid
  • Trilipix

  Eligibility

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

Inclusion Criteria:

  • A condition of general good health
  • BMI 18 to 29

Exclusion Criteria:

  • Currently enrolled in another clinical study
  • Females who are pregnant or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839293

Locations
United States, Illinois
Site Reference ID/Investigator# 16862
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Maureen Kelly, MD Abbott
  More Information

No publications provided

Responsible Party: Maureen Kelly, MD/Senior Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00839293     History of Changes
Other Study ID Numbers: M10-788
Study First Received: February 6, 2009
Last Updated: October 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Bioavailability

Additional relevant MeSH terms:
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013