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Clinical Trials in the EU / 2026-525798-38-00
Authorised, recruiting Phase I

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.

2026-525798-38-00 · tracked via the Priya Life Science EU tracker
Sponsor
Sun Pharmaceutical Industries Limited
Sponsor type
Pharmaceutical company
Therapeutic area
Digestive System Diseases
Decision date
12/10/2026
Enrollment target
112
Sites
Romania

Condition studied

Ulcerative colitis

Eligibility

Age group
18-64 years
Sex
Female, Male
Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525798-38-00 on CTIS ↗ ← All trials in the EU