NCT00939614

Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited., India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: —

Summary

* Objective: * A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fasting conditions. * Study Design: * Randomized, open label, two treatment, two period, two sequence, single dose, crossover, in 24+2 healthy human adult subjects to compare the single dose bioavailability of Torrent's Lamotrigine Tablets 2 × 25 mg and Lamictal® Tablets 2 × 25 mg of GlaxoSmithKline. Dosing periods were separated by a washout period of at least 21 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine

Timeline

• First posted: 2009-07-15
• Last updated: 2017-10-25

Locations

1 site across 1 country: India