IRCT20240804062647N8 IRCT 2025-10-30 ‎Actoverco Pharmaceutical Company Bioequivalence study of mesalazine 1200 mg extended-release tablets - Actoveerco Pharmaceutical Company Bioequivalence study of mesalazine 1200 mg extended-release tablets - Actoveerco Pharmaceutical Company 2025-12-01 anticipated 24 Recruiting https://irct.ir/trial/87005 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: At first, all of the volunteers are evaluated for meeting inclusion criteria, selecting the final participants. Each volunteer is randomly assigned to a number between 1 and 24 using simple randomization, receiving an identification card containing the assigned number. Next, at first study period, volunteers with even numbers will receive the reference drug and volunteers with odd numbers will receive the test drug. In the second period, the formulations are switched in a cross-over design. The formulation assignment to the subjects is done randomly, with the participants and the trial staff not aware the formulation administered, thus, providing the blinding situation for all stages of the study, Blinding description: This study is a single-blind (participant) clinical trial. mesalazine 1200 mg extended-release tablets - Actoverco Pharmaceutical Company and the original brand are removed from their packaging by the operator and placed in identical, coded cans. Volunteers are unaware of the type of drug or test they are receiving. Bioequivalence This study is performed on healthy volunteers.. Intervention 1: Intervention group: Single-dose of mesalazine 1200 mg extended-release tablets - Actoverco , in the first period. Cross-over design with one week wash out period.After one week in the second period, a single dose of Mesavant 1200 mg SR tablet, manufactured by Shire pharma. Intervention 2: Intervention group: Single-dose of Mesavant 1200 mg SR tablet, manufactured by Shire pharma , in the first period. Cross-over design with one week wash out period.After one week in the second period, a single dose of mesalazine 1200 mg extended-release tablets - Actoverco. No - There is not a plan to make this available Justification or reason for not sharing IPD is These data are as secure between researchers and related industries.