NCT00835263

Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions

Randomized, 2-Way, Crossover, Bioequivalence Study of Lamotrigine 200 mg Tablets and Lamictal® 200 mg Tablets Administered as 1 x 200 mg Tablet in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine	200 mg Tablet
DRUG	Lamictal®	200 mg Tablet

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-02-01
• Completion: 2002-02-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada