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IRCT20210519051345N6 IRCT 2021-11-14 Tabriz University of Medical Sciences In vivo bioequivalence study of Imatinib 100 mg capsule Fasted state in vivo bioequivalence study for Imatinib 100 mg capsule manufactured by Avicenna Co. in comparison to German brand AQVIDA 2021-11-06 anticipated 24 Complete https://irct.ir/trial/59031 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: A table of random numbers will be used. Random number tables are generated by computers that randomly set the numbers. First, a two-digit code (according to the number of volunteers, which is 24) is given to each candidate, and after creating the table, a random selection of numbers is made. To select sample people from the table, randomly start from a point in the table moving in the direction of the row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Moving in the direction of the row or column does not make any difference and this is optional. After this, the path numbers are controlled, which will be dealt with two types of numbers, one of which is smaller than the volume of the population of the study and the other is larger than the number of the population. Only smaller numbers should be considered and selected. The selected number is actually the individual code that is selected as the sample. This should be continued until enough small number can be selected based on the number of volunteers, Blinding description: In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). This means that the product will be given to the volunteers for administration outside the original packaging. Bioequivalence Fasted state in vivo bioequivalence study. Intervention 1: Intervention group: In this group, a single dose of 100 mg imatinib capsule made by Avicenna company is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by AQVIDA Co. Germany is administered. Intervention 2: Control group: In this group, a single dose of 100 mg imatinib capsule made by AQVIDA Co. Germany y is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by Avicenna company is administered. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Parvin Zakeri-Milani
Tabriz University of Medical Sciences; Faculty of Pharmacy; Attar Neishaboori street; Golgasht street
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3334 8801 pzakeri@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Parvin Zakeri-Milani
Tabriz University of Medical Sciences; Faculty of Pharmacy; Attar Neishaboori street; Golgasht street
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3334 8801 pzakeri@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) General Health including Liver, Heart and Kidney health Being at the age of 25-55 years old 20 years 60 years Both Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy Treatment - Drugs Treatment - Drugs Intervention group: In this group, a single dose of 100 mg imatinib capsule made by Avicenna company is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by AQVIDA Co. Germany is administered. Control group: In this group, a single dose of 100 mg imatinib capsule made by AQVIDA Co. Germany y is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by Avicenna company is administered. Drug Plasma Concentration. Timepoint: Blood samples will be obtained prior to dosing (baseline) and 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 3.5, 4.0; 4.5, 6.0; 8.0; 12.0; 24.0; 48.0 and 72.0 h post-dose. Method of measurement: High performance liquid chromatography (HPLC). Avicenna Pharmaceutical Co. Approved 2021-10-04 Biomedical Research Committe, Tabriz University of Medical Sciences 3rd Floor; No.2 Central Building; Tabriz University of Medical Sciences; Daneshgah street Tabriz East Azarbaijan Iran (Islamic Republic of)