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

Fasting Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06199791
Study type Interventional
Source Desitin Arzneimittel GmbH
Contact
Status Completed
Phase Phase 1
Start date April 3, 2023
Completion date June 14, 2023
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