- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00839293
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules
October 14, 2010 updated by: Abbott
Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Waukegan, Illinois, United States, 60085
- Site Reference ID/Investigator# 16862
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
ABT -335 capsules 135mg
|
Once, see arm description for more information
Other Names:
|
Experimental: B
ABT-335 capsules 45mg
|
Once, see arm description for more information
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
14 Days
|
To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage
Time Frame: 14 Days
|
14 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maureen Kelly, MD, Abbott
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
February 6, 2009
First Submitted That Met QC Criteria
February 6, 2009
First Posted (Estimate)
February 9, 2009
Study Record Updates
Last Update Posted (Estimate)
October 15, 2010
Last Update Submitted That Met QC Criteria
October 14, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-788
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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