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Completed

NCT Number: NCT02303106

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

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.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern Denmark

Odense, 5210, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy no medication use
  • Informed consent

Exclusion criteria

  • Allergy to paracetamol or lamotrigine

Treatment and study plan

Lamotrigine

Drug

Primary outcomes

  1. Lamotrigine AUC

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

Per Damkier

Other

Registry information

Official study title

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2014
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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