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An Interaction Study With Digoxin and AZD1305

NCT ID: NCT00712465

Last Updated: 2010-12-03

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

2008-08-31

Study Completion Date

2008-11-30

Brief Summary

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The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation interaction 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

AZD1305 tablet

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Extended Release tablet, repeated administration

2

AZD1305 tablet + digoxin

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Extended Release tablet, repeated administration

Digoxin

Intervention Type DRUG

Tablet, repeated administration

3

Digoxin

Group Type ACTIVE_COMPARATOR

Digoxin

Intervention Type DRUG

Tablet, repeated administration

Interventions

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AZD1305

Extended Release tablet, repeated administration

Intervention Type DRUG

Digoxin

Tablet, repeated administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria

* Potassium outside normal reference values
* ECG findings outside normal range
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Marianne Hartford, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-000577-37 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3190C00010

Identifier Type: -

Identifier Source: org_study_id