IRCT20200623047902N26 IRCT 2023-02-10 Alborz Zagros company Bioequivalence study of dimethyl fumarate 240 mg capsule Bioequivalence study of Dimethyl fumarate capsule 240 mg manufactured by Alborzzagros versus originator brand in healthy volunteers in the fasted condition 2023-04-04 anticipated 24 Complete https://irct.ir/trial/68494 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. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball, poured into a container, and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Alborz zagros's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). 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). Alborzzagros's dimethyl fumarate and Originator brand capsules 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.. Intervention 1: Intervention group: single dose, one oral capsule of Tecfidera 240 mg manufactured by Biogen, as a reference product. Intervention 2: Intervention group: Single dose, one oral capsule of Tecra 240 mg manufactured by Alborzzagros company as a test product. 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.