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IRCT20200105046010N20 IRCT 2021-01-13 Koushan Pharmed Pharmaceutical Company Study of Sitagliptine/ Metformin table In-Vivo Bioequivalence in healthy volunteers Pharmacokinetic assessments of of Sitagliptine/ Metformin 50/500 tablet (ِِDicemia) Kooshan Pharmed Co with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers 2020-12-21 anticipated 24 Complete https://irct.ir/trial/53125 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Random allocation law is the simplest method of finite randomization.This method represents a large block for the entire sample size,This means that a balance in the number of people assigned to each group will be achieved at the end of the study.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: It is necessary to apply the scientific method of blind testing in some fields, such as drug testing. 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. ِِDicemia and JANUMET are removed from their packaging by the executor and placed in similar and coded cans. Bioequivalence In this study the bioequivalence of test and brand of Sitagliptine/ Metformin tablets 50/500mg will evaluated.. Intervention 1: Intervention group: Intervention group: Single dose of Sitagliptine/ Metformin tablet 50/500mg Koushan Pharmed Company as a test product. Intervention 2: Control group: Control group:Single dose of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany). 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 (liver, heart, kidney) Body Mass Index (BMI) between 18-28 Informed consent Age between 18-60 Both male and female 18 years 60 years Both Smoking Hypersensitivity to the drug Alcohol & Drug addiction Pregnancy Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Single dose of Sitagliptine/ Metformin tablet 50/500mg Koushan Pharmed Company as a test product. Control group: Control group:Single dose of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) 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. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector. Koushan Pharmed Pharmaceutical Company Approved 2020-10-12 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)