2025-522106-20-00Not yet recruitingPhase 1
A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fasting condition.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 28 May 2025
- Start date
- 3 Jan 2026
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- EU CT number
- 2025-522106-20-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 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 | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.