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Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

NCT ID: NCT00728780

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Detailed Description

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Conditions

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Adverse Events Pharmacokinetic Variables

Keywords

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Adverse events Pharmacokinetic variables

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 15/135mg

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

once

B

ABT-335 135mg and rosuvastatin 15mg

Group Type ACTIVE_COMPARATOR

ABT-335 and rosuvastatin

Intervention Type DRUG

once

Interventions

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ABT-143

once

Intervention Type DRUG

ABT-335 and rosuvastatin

once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Condition of good health

Exclusion Criteria

* Currently enrolled in another study
* 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

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Site Reference ID/Investigator# 11101

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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M10-586

Identifier Type: -

Identifier Source: org_study_id