An Interaction Study With Digoxin and AZD1305
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: AZD1305 (Drug); Digoxin (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Helen Lunde, MD, Study Director, Affiliation: AstraZeneca R&D Mölndal, Sweden
Marianne Hartford, MD, PhD, Principal Investigator, Affiliation: AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic variables
Secondary outcome: Adverse event, vital signs, ECG, physical examination and laboratory variables.
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, GÖTEBORG, Sweden; Not yet recruiting
Additional Information
Starting date: August 2008
Ending date: December 2008
Last updated: July 9, 2008
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