Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

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.

Full Title of Study: “Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Basic Science
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2015

Interventions

• Drug: Lamotrigine

Arms, Groups and Cohorts

• Active Comparator: lamotrigine
  • lamotrigine alone
• Experimental: Lamotrigine + paracetamol
  • Lamotrigine + paracetamol

Clinical Trial Outcome Measures

Primary Measures

• Lamotrigine AUC
  • Time Frame: 24 hour

Participating in This Clinical Trial

Inclusion Criteria

• Healthy no medication use – Informed consent Exclusion Criteria:

• Allergy to paracetamol or lamotrigine

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Per Damkier
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Per Damkier, Head Consultant, MD, Ph.D. – Odense University Hospital
• Overall Official(s)
  • Per Damkier, MD, Principal Investigator, Head Consultant Clinical Pharmacology