Lamotrigine Bioequivalence

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2012
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.
Epistemonikos ID: 2a5b1926927ad4a1c9543e6c0ecab5b78e6d21ca
First added on: May 11, 2024