Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
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|ClinicalTrials.gov Identifier: NCT02303106|
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : April 22, 2015
The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Lamotrigine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: lamotrigine
Experimental: Lamotrigine + paracetamol
Lamotrigine + paracetamol
- Lamotrigine AUC [ Time Frame: 24 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303106
|University of Southern Denmark|
|Odense, Denmark, 5210|
|Principal Investigator:||Per Damkier, MD||Head Consultant Clinical Pharmacology|