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
• Trial end date: 1969-12-31

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.

• Phase: Phase 1

Details

• Lead Sponsor: Torrent Pharmaceuticals Limited
• Treatments: Anticonvulsants; Lamotrigine