NCT06199791

Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions

Single-Dose, Randomized, Two-Way Crossover, Bioequivalence of Lamotrigine 100 mg Tablet (Desitin Arzneimittel GmbH, Germany) and Lamictal 100 mg Tablet (GlaxoSmithKline GmbH & Co. KG, Germany) in Healthy, Male Volunteers, Fasting

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the bioequivalence of lamotrigine from Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg Tablet.

Detailed description

In the pivotal study bioequivalence of Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg tablet in healthy, male volunteers should be proven. The drug products were studied using a crossover design with 24 healthy, non-smoking, male volunteers being administered an oral dose of 1 × 100 mg tablet under fasting conditions.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Lamotrigine 100 MG	tablets

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-05-09
• Completion: 2023-06-14
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

1 site across 1 country: Canada