2024-513106-62-00CompletedPhase 1
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jul 2024
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 15 Apr 2024
- Start date
- 16 Dec 2024
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- EU CT number
- 2024-513106-62-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Terapia S.A. | Cluj-Napoca | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.