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IRCT20200105046010N40 IRCT 2021-09-19 Koushan Pharmed Pharmaceutical Company In-vivo Bioequivalence study of Mezasa granules with brand drugs (PENTASA Ferring Pharmaceuticals Co, Gremany) In- Vivo Bioequivalence study of Mesalazine SR. granules 2 g Kooshan Pharmed Co. (Mezasa® 2g SR. granules) with brand drugs (PENTASA® 2g SR. granules (Ferring Pharmaceuticals Co, Gremany) in Iranian healthy volunteers. 2021-09-01 anticipated 24 Complete https://irct.ir/trial/58158 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, first determine a total sample size (24 people), then write the names of the people on paper, and after folding in aluminum foil, pour it into a glass, and then randomly remove the papers and open the first 12 people in group A and The rest are selected as group B, Blinding description: Iranian Mesalazine granules and Mesalazine brand 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 medications. Bioequivalence Bio equivalence test. Intervention 1: Intervention group: will receive one test granules tablet (Mezasa® 2g SR granules Kooshan Pharmed Co). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Mesalazine in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: will receive one test granules table (PENTASA® 2g SR granules Ferring Pharmaceuticals Co, Gremany). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Mesalazine in blood samples will be 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, 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(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 - Devices Treatment - Other Intervention group: will receive one test granules tablet (Mezasa® 2g SR granules Kooshan Pharmed Co). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Mesalazine in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Control group: will receive one test granules table (PENTASA® 2g SR granules Ferring Pharmaceuticals Co, Gremany). Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Mesalazine in blood samples will be 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: High Performance Liquid Chromatography with tandem mass spectroscopy detector. Koushan Pharmed Pharmaceutical Company 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)