Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	October 21, 2008
Last Updated Date	January 27, 2009
Start Date ^†	November 2008
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00826358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg
Official Title ^†
Brief Summary	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.
Detailed Description
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Condition ^†	Healthy
Intervention ^†	Drug: ABT-143 Drug: ABT-335 Drug: rosuvastatin
Study Arms / Comparison Groups	Experimental: ABT-143 capsules 5/45mg Active Comparator: ABT-335 45mg and rosuvastatin 5mg
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	90
Completion Date
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826358
Responsible Party	Laura Williams, MD, MPH, Global Project Head, Abbott
Secondary IDs ^††
Study Sponsor ^†	Abbott
Collaborators ^††
Investigators ^†
Information Provided By	Abbott
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.