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Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

NCT02303106 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-04-22

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Lamotrigine

Sponsors & Collaborators

  • Per Damkier

    lead OTHER

Principal Investigators

  • Per Damkier, MD · Head Consultant Clinical Pharmacology

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303106 on ClinicalTrials.gov