A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 8087

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy male or female subjects

Exclusion criteria

Clinically significant diseases or disorders
Positive screens for drug and alcohol
Pregnant or breast-feeding females
Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Treatment and study plan

ABT-335

Drug

One ABT-335 135 mg capsule QD for 10 days

Other names: fenofibric acid

atorvastatin

Drug

One 80 mg tablet of atorvastatin QD for 10 days

Other names: atovastatin

ezetimibe

Drug

One ezetimibe 10 mg tablet QD for 10 days

Primary outcomes

PK interaction

Time frame: Study duration approximately 62 days

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
First posted: May 21, 2008
Registry last updated: Oct 19, 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.

Published trials that share one or more normalized conditions with this study.

Completed