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IRCT20200407046981N27 IRCT 2022-03-18 Avicenna Pharmaceutical Company Study of absorption and elimination rate of Dimethyl Fumarate 240-mg capsule in comparison with Dimethyl Fumarate brand Capsule (Tecfidera®). Comparative bioequivalence study of the Dimethyl Fumarate 240-mg Capsules manufactured by Avicenna Pharmaceutical Company versus Tecfidera® (Biogen) 2022-10-06 anticipated 24 Complete https://irct.ir/trial/62472 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period. Bioequivalence Bioequivalence study. 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is No - There is not a plan to make this available
public Hamed Hamishehkar
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3336 7914 Hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Jaber Emami
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 3792 7111 Emami@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 60 years Male Known hypersensitivity or idiosyncratic reaction to Dimethyl Fumarate or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two weeks before dosing. Treatment - Drugs Treatment - Drugs 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 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. 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). 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. Avicenna Pharmaceutical Company Approved 2022-03-01 Ethics committee of Tabriz University of Medical Science Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)