An Interaction Study With Digoxin and AZD1305

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712465

Enrollment

Registered

2008-07-10

Start date

2008-08-31

Completion date

2008-11-30

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, interaction, pharmacokinetic

Brief summary

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.

Interventions

DRUGAZD1305

Extended Release tablet, repeated administration

DRUGDigoxin

Tablet, repeated administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables	During all dosing visits

Secondary

Measure	Time frame
Adverse event, vital signs, ECG, physical examination and laboratory variables.	During the study

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026