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Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Per Damkier

Official(s) and/or principal investigator(s):
Per Damkier, MD, Principal Investigator, Affiliation: Head Consultant Clinical Pharmacology


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.

Clinical Details

Official title: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Lamotrigine AUC


Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.


Inclusion Criteria:

- Healthy no medication use

- Informed consent

Exclusion Criteria:

- Allergy to paracetamol or lamotrigine

Locations and Contacts

University of Southern Denmark, Odense 5210, Denmark
Additional Information

Starting date: November 2014
Last updated: April 21, 2015

Page last updated: August 23, 2015

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