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IRCT20200105046010N43 IRCT 2021-10-30 ABIDI Pharmaceutical Company In-vivo Bioequivalence Test of Dimethyl fumarate Capsules with brand drug (TECFIDERA® 240 mg, Biogen, Germany) In- Vivo Bioequivalence Study of Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. َAbidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers. 2021-11-03 anticipated 24 Complete https://irct.ir/trial/59642 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this reason, A 24- person group will be selected and divided to two 12-person groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B, Blinding description: Candidates are not aware of receiving the test drug or brand one. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Test and brand drug (Dimethyl fumarate Capsules) are withdrawal from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about the types of receiving drugs (test or brand). Bioequivalence Bioequivalence Study. Intervention 1: Intervention group: they will receive one test drug (Dimethyl fumarate 240 mg Entric-coated Capsulesو ABIDI Pharma. Iran). Blood samples will be taken during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by liquid chromatography- Tandem mass spectroscopy method. Intervention 2: Control group: will receive one test drug (TECFIDERA® 240 mg, Biogen, Germany). Blood samples will be taken from the volunteers during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by High performance liquid chromatography- Tandem mass spectroscopy method. No - There is not a plan to make this available Justification or reason for not sharing IPD is These date are as secure between researcher and related industries
public Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences scientific Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 Shokri.j@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old 18 years 60 years Both Smoking History of cardiovascular disease History of liver or kidney disease Pregnancy Alcohol & Drug addiction History of hypersensitivity Treatment - Other Other Intervention group: they will receive one test drug (Dimethyl fumarate 240 mg Entric-coated Capsulesو ABIDI Pharma. Iran). Blood samples will be taken during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by liquid chromatography- Tandem mass spectroscopy method. Control group: will receive one test drug (TECFIDERA® 240 mg, Biogen, Germany). Blood samples will be taken from the volunteers during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by High performance liquid chromatography- Tandem mass spectroscopy method. Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography tandem mass spectroscopy. ABIDI Pharmaceutical Company Approved 2021-05-17 Ethics Committee, Tabriz University of Medical Sciences Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St. Tabriz East Azarbaijan Iran (Islamic Republic of)