Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Per Damkier12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LamotrigineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy no medication use * Informed consent Exclusion Criteria: * Allergy to paracetamol or lamotrigine

Locations (1)

University of Southern Denmark

Odense, Denmark

Outcomes

Primary Outcomes

Lamotrigine AUC

Time frame: 24 hour

Data from ClinicalTrials.gov

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