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

NCT ID: NCT00681525

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

ABT-335 135 mg

Group Type EXPERIMENTAL

ABT-335

Intervention Type DRUG

One ABT-335 135 mg capsule QD for 10 days

B

Atorvastatin 80 mg and Ezetimibe 10 mg

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

One 80 mg tablet of atorvastatin QD for 10 days

Ezetimibe

Intervention Type DRUG

One ezetimibe 10 mg tablet QD for 10 days

C

ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg

Group Type EXPERIMENTAL

ABT-335

Intervention Type DRUG

One ABT-335 135 mg capsule QD for 10 days

Atorvastatin

Intervention Type DRUG

One 80 mg tablet of atorvastatin QD for 10 days

Ezetimibe

Intervention Type DRUG

One ezetimibe 10 mg tablet QD for 10 days

Interventions

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ABT-335

One ABT-335 135 mg capsule QD for 10 days

Intervention Type DRUG

Atorvastatin

One 80 mg tablet of atorvastatin QD for 10 days

Intervention Type DRUG

Ezetimibe

One ezetimibe 10 mg tablet QD for 10 days

Intervention Type DRUG

Other Intervention Names

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fenofibric acid atovastatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 8087

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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M10-367

Identifier Type: -

Identifier Source: org_study_id