- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00808678
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium
September 27, 2012 updated by: AstraZeneca
The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
Florida
-
Orlando, Florida, United States, 32809
- Site Reference ID/Investigator# 14762
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A condition of general good health
- BMI 19 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: 1
ABT-143 capsules 20/135 mg
|
once, see arm description for more information
|
Active Comparator: 2
ABT-335 135 mg and rosuvastatin 20 mg
|
once, see arm description for more information
once, see arm description for more detail
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and tolerability of ABT-143 vs (ABT-335 + rosuvastatin) in healthy adults
Time Frame: 7 days
|
7 days
|
To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Torbjörn Lundström, MD, AstraZeneca
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
December 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
December 2, 2008
First Submitted That Met QC Criteria
December 12, 2008
First Posted (Estimate)
December 16, 2008
Study Record Updates
Last Update Posted (Estimate)
September 28, 2012
Last Update Submitted That Met QC Criteria
September 27, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-662
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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