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NCT02303106 Clinical Trial

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Healthy Clinical Trial

Official title:
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02303106
Other study ID # AKF-386
Secondary ID
Status Completed
Phase Phase 4
First received November 21, 2014
Last updated April 21, 2015
Start date November 2014
Est. completion date April 2015

Study information
Verified date April 2015
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Healthy no medication use

- Informed consent

Exclusion Criteria:

- Allergy to paracetamol or lamotrigine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Lamotrigine

Locations
Country Name City State
Denmark University of Southern Denmark Odense

Sponsors (1)
Lead Sponsor Collaborator
Per Damkier

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lamotrigine AUC 24 hour No
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