Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Per Damkier

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT02303106

AKF-386

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy no medication use
• Informed consent

Exclusion criteria

• Allergy to paracetamol or lamotrigine

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

lamotrigine

Active Comparator group

Description:

lamotrigine alone

Treatment:

Drug: Lamotrigine

Lamotrigine + paracetamol

Experimental group

Description:

Lamotrigine + paracetamol

Treatment:

Drug: Lamotrigine