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
  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:


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
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: 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 October 16, 2014