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OpenTrials
Completed

NCT Number: NCT00839293

Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 16862

Waukegan, Illinois, 60085, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-335

Drug

Once, see arm description for more information

Other names: fenofibric acid, Trilipix

Primary outcomes

  1. 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

    Time frame: 14 Days

  2. To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage

    Time frame: 14 Days

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules

Important dates

Study start
2009
Primary completion
2009
First posted
Feb 9, 2009
Registry last updated
Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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