Study of absorption and elimination rate of Dimethyl Fumarate 240-mg capsule in comparison with Dimethyl Fumarate brand Capsule (Tecfidera®)

INTERVENTION: Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Dimethyl Fumarate 240‐mg capsule produced by Avicenna Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2. Intervention 2: Intervention group 2: In this group, volunteers are given a single oral dose of Dimethyl Fumarate 240‐mg Capsule (Tecfidera®), produced by Biogen Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1. CONDITION: Bioequivalence study. PRIMARY OUTCOME: Peak Plasma Concentration (Cmax). Timepoint: At 0 before dosing 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 10 and 12 hours after dosing. Method of measurement: High‐performance liquid chromatography—mass spectrometry (HPLC‐MS). SECONDARY OUTCOME: AUC (Area Under the Concentration‐Time Curve). Timepoint: At 0 before dosing 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 10 and 12 hours after dosing. Method of measurement: Using non‐compartmental model of Win‐Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. INCLUSION CRITERIA: The weight limit of each volunteer should be between 60 and 100 kg. All volunteers must be non‐smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. Candidates who have consented to the consent form.