NCT01513720

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This is an single dose,two-way, crossover, oral bioequivalence study.

Detailed description

The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2012-01-20
• Last updated: 2012-01-20

Locations

1 site across 1 country: United States