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Completed

NCT Number: NCT00712465

An Interaction Study With Digoxin and AZD1305

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1305

Drug

Extended Release tablet, repeated administration

Digoxin

Drug

Tablet, repeated administration

Primary outcomes

  1. Pharmacokinetic variables

    Time frame: During all dosing visits

Secondary outcomes

  1. Adverse event, vital signs, ECG, physical examination and laboratory variables.

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Open, Single-centre, Three-period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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