Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02303106

Enrollment

Registered

2014-11-27

Start date

2014-11-30

Completion date

2015-04-30

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AUC exposure to lamotrigine

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.

Interventions

DRUGLamotrigine

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy no medication use * Informed consent

Exclusion criteria

* Allergy to paracetamol or lamotrigine

Design outcomes

Primary

Measure	Time frame
Lamotrigine AUC	24 hour

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026