An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Lamotrigine Dispersible Tablets BP 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Lamictal (Lamotrigine) Dispersible Tablets 100 mg, Manufactured by: Delpharm Poznaÿ – Poland & Registered and Imported by: GlaxoSmithKline Brasil Ltda, in healthy adult, human subjects under fasting condition.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513106-62-00

Acronym

LAMOT-04-24

Enrollment

Registered

2024-07-29

Start date

2024-12-16

Completion date

2025-02-14

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder, Epilepsy

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Romania

None listed

Source: EU CTIS · Data processed: Feb 4, 2026