2025-520617-31-00CompletedPhase 1
An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fasting condition.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Jun 2025
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 28 Feb 2025
- Start date
- 12 Sept 2025
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- EU CT number
- 2025-520617-31-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 112
- 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.