NCT01995825

Lamotrigine Bioequivalence

Evaluation of Bioequivalence of Lamotrigine Tablets in Epileptic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e. test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative hypothesis is that the generic is bioequivalent to the brand name.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brand lamotrigine	Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
DRUG	Generic lamotrigine	Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-11-27
• Last updated: 2020-12-01
• Results posted: 2020-12-01

Locations

1 site across 1 country: United States