Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00839293

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 I

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:

Drug Information available for: Procetofen

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

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 February 09, 2012