Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Per Damkier
• Treatments: Acetaminophen; Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• Healthy no medication use

• Informed consent

Exclusion Criteria:

• Allergy to paracetamol or lamotrigine