Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
NCT ID: NCT01704638
Last Updated: 2015-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2008-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
fluvoxamine
Digoxin
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
fluvoxamine
Digoxin
Interventions
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fluvoxamine
Digoxin
Eligibility Criteria
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Inclusion Criteria
* Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)
* Normal P-potassiumvalue (3,6-4,6 mmol/L)
* HF\>50 and no AV-block on resting ECG. No other significant abnormalities as judged by the investigator.
* Subject giving written informed consent
* Subject capable of understanding instructions
Exclusion Criteria
* Ongoing infection
* Intake of medication, including natural remedies (for example St John´s wort), within one month prior to starting study except for paracetamol.
* Active drug or alcohol abuse
18 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Erik Sparve
MD, specialist in clinical pharmacology
Locations
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CPTU
Stockholm, , Sweden
Countries
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Other Identifiers
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fluvoxaminedigoxin
Identifier Type: -
Identifier Source: org_study_id
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