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Trial record 6 of 215 for:    Lamotrigine

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02303106
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Per Damkier, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lamotrigine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Active Comparator: lamotrigine
lamotrigine alone
Drug: Lamotrigine
Experimental: Lamotrigine + paracetamol
Lamotrigine + paracetamol
Drug: Lamotrigine

Primary Outcome Measures :
  1. Lamotrigine AUC [ Time Frame: 24 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy no medication use
  • Informed consent

Exclusion Criteria:

  • Allergy to paracetamol or lamotrigine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02303106

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University of Southern Denmark
Odense, Denmark, 5210
Sponsors and Collaborators
Per Damkier
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Principal Investigator: Per Damkier, MD Head Consultant Clinical Pharmacology

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Responsible Party: Per Damkier, Head Consultant, MD, Ph.D., Odense University Hospital Identifier: NCT02303106     History of Changes
Other Study ID Numbers: AKF-386
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Per Damkier, Odense University Hospital:
AUC exposure to lamotrigine
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers