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IRCT20200105046010N48 IRCT 2021-12-19 Arena Hayat Danesh Pharmaceutical Company In-vivo Bioequivalence Test of Flecainide acetate tablets with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) In- Vivo Bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma. (TAMONID® 100mg) with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) in Iranian healthy volunteers. 2021-12-08 anticipated 24 Complete https://irct.ir/trial/60509 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, A 24- persons group will be selected and divided to two 12-persons 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 The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B, Blinding description: Candidates are not aware of receiving the test drug or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 drugs 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 drug. Bioequivalence Bio equivalence test. Intervention 1: Intervention group: One test tablet (Flecainide tablet 100 mg produced by Arena Hayate Danesh Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers. Intervention 2: Control group: One Reference tablet (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Flecainide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers. 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 18-55 years old 18 years 55 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: One test tablet (Flecainide tablet 100 mg produced by Arena Hayate Danesh Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers. Control group: One Reference tablet (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Flecainide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers. Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. Arena Hayat Danesh Pharmaceutical Company Approved 2021-11-15 Ethics Committee of Tabriz University of Medical Sciences Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St. Tabriz East Azarbaijan Iran (Islamic Republic of)