NCT02303106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

November 21, 2014

Last Update Submit

April 21, 2015

Conditions

Healthy

Keywords

AUC exposure to lamotrigine

Outcome Measures

Primary Outcomes (1)

  • Lamotrigine AUC

    24 hour

Study Arms (2)

lamotrigine

ACTIVE COMPARATOR

lamotrigine alone

Drug: Lamotrigine

Lamotrigine + paracetamol

EXPERIMENTAL

Lamotrigine + paracetamol

Drug: Lamotrigine

Interventions

LamotrigineDRUG
Lamotrigine + paracetamollamotrigine

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy no medication use
  • Informed consent

You may not qualify if:

  • Allergy to paracetamol or lamotrigine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5210, Denmark

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Per Damkier, MD

    Head Consultant Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Consultant, MD, Ph.D.

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

DK(1)