An interaction study with digoxin and AZD1305

Study identifier:D3190C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official 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

Medical condition

Atrial Fibrillation

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1305, Digoxin

Sex

Male

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Aug 2008

Primary Completion Date: 01 Nov 2008

Study Completion Date: 01 Nov 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

GÖTEBORG, Sweden

Arms	Assigned Interventions
Experimental: 1 AZD1305 tablet	Drug: AZD1305 Extended Release tablet, repeated administration
Experimental: 2 AZD1305 tablet + digoxin	Drug: AZD1305 Extended Release tablet, repeated administration Drug: Digoxin Tablet, repeated administration
Active Comparator: 3 Digoxin	Drug: Digoxin Tablet, repeated administration

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1325&filename=CSR-D3190C00010.pdf
Download
CSR-D3190C00010.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Helen Lunde

AstraZeneca R&D Mölndal, Sweden