NCT00838136

Lamotrigine 25 mg Chewable Tablets, Non-Fasting

Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets 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 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets 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 25 mg Chewable Tablets	2 x 25 mg, single-dose fed
DRUG	Lamictal® 25 mg Chewable Tablets	2 x 25 mg, single-dose fed

Timeline

• Start date: 2002-02-01
• Primary completion: 2002-03-01
• Completion: 2002-03-01
• First posted: 2009-02-06
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada