NCT01888731

Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 50 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing Lamotrigine) Extended Release tablets 50mg of GlaxoSmithKline Research Triangle Park, NC in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine	Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2013-06-28
• Last updated: 2013-06-28

Locations

1 site across 1 country: India