Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Lamotrigine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Per Damkier Official(s) and/or principal investigator(s):
Per Damkier, MD, Principal Investigator, Affiliation: Head Consultant Clinical Pharmacology
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.
Clinical Details
Official title: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Lamotrigine AUC
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy no medication use
- Informed consent
Exclusion Criteria:
- Allergy to paracetamol or lamotrigine
Locations and Contacts
University of Southern Denmark, Odense 5210, Denmark
Additional Information
Starting date: November 2014
Last updated: April 21, 2015
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