IRCT20200105046010N94 IRCT 2024-02-12 Tasnim company Bioequivalence study of Mesalazine 1200 mg sustained release tablet Bioequivalence study of Mesalazine 1200 mg sustained release tablet (Intesa 1200mg) manufactured by Tasnim Co. versus originator brand Pentasa 1200mg tablet manufactured by Ferring Pharmaceuticals in fasting condition in healthy volunteers 2024-02-20 anticipated 24 Complete https://irct.ir/trial/75391 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. People are randomly placed in one of the two study groups with the help of a random number table and receive the intervention related to the same group. The volunteers don't have any information about taking the test drug or brand drug, Blinding description: This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form. Bioequivalence This study is performed on healthy volunteers and drug concentration in plasma is determined.. Intervention 1: Intervention group: single dose, one oral Pentasa 1200 mg tablet manufactured by Ferring Pharmaceuticals as a reference product. after the washout period, the volunteers receive Intasa 1200 mg tablet manufactured by Tasnim Co. Intervention 2: Intervention group: Single dose, Intasa 1200mg tablet manufactured by Tasnim company as a test product. after the washout, the volunteers receive Pentasa 1200mg tablet manufactured by Ferring Pharmaceuticals. 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.