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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.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522106-20-00
Acronym
MESAL-03-25
Enrollment
112
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

ulcerative colitis

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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