Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-335

• Registration Number: NCT00839293
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2009-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-14
• Last Update Posted: 2010-10-15

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	ABT-335	ABT-335 capsules 45mg
A	ABT-335	ABT -335 capsules 135mg

Primary Outcome Measures

Name	Time	Method
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	14 Days
To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage	14 Days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 16862; 🇺🇸 Waukegan, Illinois, United States