- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02303106
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Odense, Denmark, 5210
- University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy no medication use
- Informed consent
Exclusion Criteria:
- Allergy to paracetamol or lamotrigine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: lamotrigine
lamotrigine alone
|
|
Experimental: Lamotrigine + paracetamol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lamotrigine AUC
Time Frame: 24 hour
|
24 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Per Damkier, MD, Head Consultant Clinical Pharmacology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
Other Study ID Numbers
- AKF-386
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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