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.

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.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adults to compare two mesalamine 400 mg delayed release capsules. Each person takes a single dose under fasting conditions.

Age

18 to 64 years

Sex

Women and men can join.

This trial only enrols healthy participants. The registry sentence this rests on: healthy, adult, human subjects under fasting condition

Read by machine on 9 Nov 2026.

Sites (1)

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