NCT00650208

Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Lamotrigine Tablets (25 mg; Mylan) to Lamictal® Tablets (25 mg; GSK) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine Tablets 25 mg	2x25mg, single dose fasting
DRUG	Lamictal® Tablets 25 mg	2x25mg, single dose fasting

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States