Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
NCT ID: NCT02303106
Last Updated: 2015-04-22
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
PHASE4
12 participants
INTERVENTIONAL
2014-11-30
2015-04-30
Brief Summary
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Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.
Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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lamotrigine
lamotrigine alone
Lamotrigine
Lamotrigine + paracetamol
Lamotrigine + paracetamol
Lamotrigine
Interventions
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Lamotrigine
Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
18 Years
64 Years
MALE
Yes
Sponsors
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Per Damkier
OTHER
Responsible Party
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Per Damkier
Head Consultant, MD, Ph.D.
Principal Investigators
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Per Damkier, MD
Role: PRINCIPAL_INVESTIGATOR
Head Consultant Clinical Pharmacology
Locations
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University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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AKF-386
Identifier Type: -
Identifier Source: org_study_id
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