Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Lamotrigine

• Registration Number: NCT02303106
• Lead Sponsor: Per Damkier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy no medication use
• Informed consent

Exclusion Criteria

• Allergy to paracetamol or lamotrigine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
lamotrigine	Lamotrigine	lamotrigine alone
Lamotrigine + paracetamol	Lamotrigine	Lamotrigine + paracetamol

Primary Outcome Measures

Name	Time	Method
Lamotrigine AUC	24 hour

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark