Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

Phase 1

Completed

• Conditions: Adverse Events; Pharmacokinetic Variables
• Interventions: Drug: ABT-143; Drug: ABT-335 and rosuvastatin

• Registration Number: NCT00728780
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-06
• Primary Completion: 2008-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Signed informed consent
• Condition of good health

Exclusion Criteria

• Currently enrolled in another study
• Females who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	ABT-143	ABT-143 15/135mg
B	ABT-335 and rosuvastatin	ABT-335 135mg and rosuvastatin 15mg

Primary Outcome Measures

Name	Time	Method
Adverse events and safety laboratory assessments	7 days
Pharmacokinetic parameters	7 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 11101; 🇺🇸 Evansville, Indiana, United States