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Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

NCT ID: NCT00681395

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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To evaluate 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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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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1

ABT-143 capsules 20/135 mg

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

once daily for 6 days

2

ABT-335 135mg and rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

ABT-335

Intervention Type DRUG

once daily for six days

Rosuvastatin

Intervention Type DRUG

Once daily for 6 days

3

ABT-143 capsules 5/45mg

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

once daily for 6 days

4

ABT-335 45mg and rosuvastatin 5mg

Group Type ACTIVE_COMPARATOR

ABT-335

Intervention Type DRUG

once daily for six days

Rosuvastatin

Intervention Type DRUG

Once daily for 6 days

Interventions

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ABT-143

once daily for 6 days

Intervention Type DRUG

ABT-335

once daily for six days

Intervention Type DRUG

Rosuvastatin

Once daily for 6 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* General good health
* BMI 19 to 29

Exclusion Criteria

* Currently enrolled in another study
* Females who are pregnant or breastfeeding
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# 8089

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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M10-360

Identifier Type: -

Identifier Source: org_study_id