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IRCT20200105046010N63 IRCT 2022-06-26 Pharan shimi Pharmaceutical Company In-vivo Bioequivalence Test of Mesalasine 500 mg EC tablet Faran shimi Pharma with brand drug (Asacol® 400 mg ER. Tablets. ُTillotts Pharma AG, Switzerland) In- Vivo Bioequivalence study of Mesalasine 500 mg EC tablet Faran shimi Pharma with brand drugs (Asacol® 400 mg ER. Tablets. ُTillotts Pharma AG, Switzerland) in Iranian healthy volunteers. 2022-06-26 anticipated 24 Complete https://irct.ir/trial/64361 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 The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B, Blinding description: Candidates are not aware of receiving the test drug or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 single 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: One test tablet ( Mesalasine 500 mg EC tablet Faran shimi Pharma ) will be received. Blood samples will be taken for 24 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. Intervention 2: Control group: One Reference tablet Asacol® 400 mg ER. Tablets. ُTillotts Pharma AG, Switzerland will be received. Blood samples will be taken for 48 hours at the mentioned times after drug administration and the concentration of drug in plasma 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 All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
public Dariush Omidfar
No.48, Ferdos square
Tabriz Iran (Islamic Republic of) 5167874434 +98 41 3384 2724 Dariush.omidfar@gmail.com Simin Baspar Teyf Gostar Company 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 18-60 years old 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 One test tablet ( Mesalasine 500 mg EC tablet Faran shimi Pharma ) will be received. Blood samples will be taken for 24 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 Control group: One Reference tablet Asacol® 400 mg ER. Tablets. ُTillotts Pharma AG, Switzerland will be received. Blood samples will be taken for 48 hours at the mentioned times after drug administration and the concentration of drug in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. Plasma drug concentration. Timepoint: Sampling times in this study will be 0، 1، 2، 3،4، 6، 6.5، 7، 7.5، 8، 9، 10، 10.5، 11، 12 ، 24 ,48 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. Pharan shimi Pharmaceutical Company Approved 2021-11-29 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)