drugset / Trial / NCT02303106
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
Non-randomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1 g | — |
| Subject | Lamotrigine | Small molecule | 100 mg | — |
Indications
No indication recorded.