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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00826358
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ABT-143; Drug: ABT-335; Drug: rosuvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A ABT-143 capsules 5/45mg	Drug: ABT-143; Once, please see Arm Description for more details.
Active Comparator: B ABT-335 45mg and rosuvastatin 5mg	Drug: ABT-335; Once, see Arm Description for more detail; Drug: rosuvastatin; once, see Arm Description for more detail

Outcome Measures

Primary Outcome Measures

1. To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [7 days]

2. To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. A condition of general good health

2. BMI 19 to 29

Exclusion Criteria:

1. Currently enrolled in another clinical study

2. Females who are pregnant or breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 13441	Orlando	Florida	United States	32809

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Torbjörn Lundström, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00826358
• Other Study ID Numbers: M10-535
• First Posted: Jan 22, 2009
• Last Update Posted: Sep 28, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AstraZeneca: Adverse events; Pharmacokinetic
• Additional relevant MeSH terms: Rosuvastatin Calcium

Study Results

No Results Posted as of Sep 28, 2012