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
20 participants
INTERVENTIONAL
2013-01-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Metformin
7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated.
Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again
St John's Wort
Metformin
Interventions
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St John's Wort
Metformin
Eligibility Criteria
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Inclusion Criteria
* Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
* Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose
Exclusion Criteria
* Hypersensitivity to metformin or St John's Wort
* Daily intake of drugs requiring prescription
18 Years
64 Years
MALE
Yes
Sponsors
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University of Southern Denmark
OTHER
Responsible Party
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Tore B. Stage
M.Sc. Pharm
Principal Investigators
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Per Damkier, MD ph.d.
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Tore B. Stage, M.Sc. Pharm
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Kim Brøsen, Professor, MD
Role: STUDY_DIRECTOR
University of Southern Denmark
Locations
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Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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AKF-382
Identifier Type: -
Identifier Source: org_study_id