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IRCT20200105046010N19 IRCT 2021-01-10 Pharan shimi Pharmaceutical Company In-vivo Bioequivalence Test Fampridine tablet with brand drug FAMPYRA Made by Biogen Idec, UK. Pharmacokinetic assessments of Fampridine tablet 10mg extended release in comparison with brand drugs FAMPYRA 2021-03-05 anticipated 24 Complete https://irct.ir/trial/52850 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Random allocation law will be used for randomization of volunteers in this study. By this method, sequences 1(subjects no: 1-12) and sequences 2 (subjects no: 13-12) will be selected by using a simple paper lottery. the first and second 12 persons will be considered as sequence 1 (Group A) and sequence 2 (Group B) respectively, Blinding description: Candidates are not aware of the test drug or brand name. 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. Fampridine and FAMPYRA 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 The aim of this study is evaluation of bioequivalence of test and reference drugs and the study will one by healthy volunteers. Intervention 1: Intervention group: Intervention group received one test drug table (Fampridine 10 mg Pharan shimi Company). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: Control group received one test drug table (FAMPYRA 10mg Biogen Idec, UK.). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector. No - There is not a plan to make this available Justification or reason for not sharing IPD is All data of the study between executor and employer will remain confidential.
public Javad Shokri
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
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, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
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 (BMI) between 18-28 Informed consent Age between 18-60 Both male and female 18 years 60 years Both Smoking Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug Treatment - Drugs Treatment - Drugs Intervention group: Intervention group received one test drug table (Fampridine 10 mg Pharan shimi Company). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector. Control group: Control group received one test drug table (FAMPYRA 10mg Biogen Idec, UK.). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector. Blood concentration of the drug. 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 received tablet. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector. Pharan shimi Pharmaceutical Company Approved 2020-12-29 Ethics Committee, Tabriz University of Medical Sciences Third floor of TUMS (Tabriz University of Medical Sciences) central building, Dneshgah St. Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)