drugset / Trial / NCT02303106

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

NCT02303106

Phase 4 Completed 12 enrolled Per Damkier
Non-randomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start
2014-11
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1 g
Subject Lamotrigine Small molecule 100 mg

Indications

No indication recorded.