🇺🇸 FDA
Pipeline program

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 fed condition.

MESAL-02-25

Phase 1 other active

Quick answer

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 fed condition. for ulcerative colitis is a Phase 1 program (other) at Lacuna Pharma Pty Ltd with 1 ClinicalTrials.gov record(s).

Program details

Company
Lacuna Pharma Pty Ltd
Indication
ulcerative colitis
Phase
Phase 1
Modality
other
Status
active

Clinical trials