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OpenTrials
Completed

NCT Number: NCT00826358

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

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.

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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# 13441

Orlando, Florida, 32809, 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 19 to 29

Exclusion criteria

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

Treatment and study plan

ABT-143

Drug

Once, please see Arm Description for more details.

ABT-335

Drug

Once, see Arm Description for more detail

Rosuvastatin

Drug

once, see Arm Description for more detail

Primary outcomes

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

    Time frame: 7 days

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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Jan 22, 2009
Registry last updated
Sep 28, 2012

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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