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IRCT20200105046010N28 IRCT 2021-04-11 ARENA Pharmaceutical Company In-vivo Bioequivalence Test of Ticagrelor® tablet with brand drugs (BRILINTA® AstraZeneca UK). In- Vivo Bioequivalence study of Ticagrelor tablet 90mg ARENA Pharmaceuticals (TICALIX® 90mg Tablets) with brand drugs (BRILINTA® 90mg, AstraZeneca UK) in Iranian healthy volunteers. 2021-04-06 anticipated 24 Complete https://irct.ir/trial/55361 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. This method represents a large block for the total sample size, which means that a balance in the number of people assigned to each group will be obtained at the end of the 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. Tramadol and Tramadol 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 In this study, the disease is not examined. Subject bioequivalence test and reference tablets Ticagrelor studied.. Intervention 1: Intervention group: Intervention group received one test drug table(Ticagrelor tablet 90 mg ARENA Pharmaceuticals ). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Ticagrelor in blood samples was measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: Control group received one reference drug table(Ticagrelor tablet 90 mg BRILINTA® AstraZeneca UK). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Ticagrelor 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 These date are as secure between researcher and related industries
public Javad Shokri
Faculty of Pharmacy, Tabriz University of Medical Sciences.
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.
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(18-28) Informed consent Age(18-60) 18 years 60 years Both Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug Treatment - Other Treatment - Other Intervention group: Intervention group received one test drug table(Ticagrelor tablet 90 mg ARENA Pharmaceuticals ). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Ticagrelor in blood samples was measured by liquid chromatography with mass spectroscopy detector. Control group: Control group received one reference drug table(Ticagrelor tablet 90 mg BRILINTA® AstraZeneca UK). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Ticagrelor in blood samples was measured by liquid chromatography with mass spectroscopy detector. Determination of blood 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: igh Performance Liquid Chromatography with tandem mass spectroscopy detector. Tabriz University of Medical Sciences Approved 2021-03-01 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)