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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

NCT ID: NCT00826358

Last Updated: 2012-09-28

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Adverse events Pharmacokinetic

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-143 capsules 5/45mg

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

Once, please see Arm Description for more details.

B

ABT-335 45mg and rosuvastatin 5mg

Group Type ACTIVE_COMPARATOR

ABT-335

Intervention Type DRUG

Once, see Arm Description for more detail

rosuvastatin

Intervention Type DRUG

once, see Arm Description for more detail

Interventions

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ABT-143

Once, please see Arm Description for more details.

Intervention Type DRUG

ABT-335

Once, see Arm Description for more detail

Intervention Type DRUG

rosuvastatin

once, see Arm Description for more detail

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A condition of general good health
2. BMI 19 to 29

Exclusion Criteria

1. Currently enrolled in another clinical study
2. Females who are pregnant or breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torbjörn Lundström, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Site Reference ID/Investigator# 13441

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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M10-535

Identifier Type: -

Identifier Source: org_study_id