NCT01131975

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

Single Dose Two-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets With Lamictal 25 mg Chewable Tablets in Healthy Volunteers Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

Detailed description

A single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine	Lamotrigine Tablets (chewable, dispersible), 25 mg

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-02-01
• Completion: 2003-03-01
• First posted: 2010-05-27
• Last updated: 2010-06-14

Locations

1 site across 1 country: United States