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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00723424 |
The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteers Pharmacokinetics |
Drug: AZD5672 Drug: Digoxin |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study to Assess the Effect of AZD5672 at Steady State on the Pharmacokinetics of Digoxin Following Single Dose Administration in Healthy Volunteers |
Estimated Enrollment: | 24 |
Study Start Date: | July 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
AZD5672 + Digoxin (single dose on day 12)
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Drug: AZD5672
50 mg, for 13 days
Drug: Digoxin
0.5mg dose
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2: Experimental
AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)
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Drug: AZD5672
50 mg, for 13 days
Drug: Digoxin
0.5mg dose
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Research Site | |
Berlin, Germany |
Study Director: | Rod Hepburn | AstraZeneca R&D, Charnwood, UK |
Principal Investigator: | Rainard Fuhr | PAREXEL International GmbH |
Responsible Party: | AstraZeneca R&D Alderely Park ( Mark Layton, MD, PhD, Medical Science Director ) |
Study ID Numbers: | D1710C00021, EudraCt nr 2007-007542-34 |
Study First Received: | July 24, 2008 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00723424 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
AZD5672 digoxin |
Digoxin Anti-Arrhythmia Agents Cardiovascular Agents Healthy |
Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Therapeutic Uses Physiological Effects of Drugs Digoxin |
Enzyme Inhibitors Anti-Arrhythmia Agents Cardiovascular Agents Protective Agents Pharmacologic Actions |